85beb4c0-49be-4351-b700-ee2fc36a7ab6

SA
M
PL
E
PD
F
G
PA
T
AT
YO
U
R
FI
N
G
ER
TI
P S
SA
M
PL
E
PD
F
G
PA
T
AT
YO
U
R
FI
N
G
ER
TI
P S
SA
M
PL
E
PD
F
G
PA
T
AT
YO
U
R
FI
N
G
ER
TI
P S
SA
M
PL
E
PD
F
G
PA
T
AT
YO
U
R
FI
N
G
ER
TI
P S
S
1
P
TI
PART
ER
G
N
FI
R
PHARMACEUTICS U
YO
AT
T
PA
G
F
PD
E
PL
Ä Physical Pharmacy
M
Ä Dispensing Pharmacy
Ä Hospital Pharmacy
SA
Ä Cosmetic Technology
Ä Pharmaceutical Engineering
Ä Pharmaceutical Technology
Ä Biopharmaceutics
Ä Pharmaceutical Jurisprudence
PHARMACEUTICS : PHYSICAL PHARMACY
SP
TI
ER
 Three states of matter are :- Solid , Liquid, Gas and Plasma is the fourth state of matter
that seldom occurs on the earth.
G
 The state of matter that shows the uniformity of behavior.
N
SOLID LIQUID GAS PLASMA
FI
Have strong Weak intermolecular Very weak Negligible
intermolecular force. force. intermolecular force.
R
Very less Large intermolecular Very large Particles are far
intermolecular space. U
intermolecular space. apart as in a gas
YO
space.
Have definite shape Do not have definite No definite shape Not have fixed
and volume shape but have and volume shape
AT
definite volume
Have high density Density is low Very low density Flow in all
direction
T
Solids cannot be Liquids can be Gases can be highly Highly

PA
compressed compressed compressed compressible

G
F
PD
 CRYSTALS
 Crystal lattice is constructed from repeating units called unit cells.

E
 External appearance of a crystal is described by crystal habits, such as needles, prisms,

PL
rosettes etc.
 Polymorphism is the ability of a compound to crystallize as more than one distinct
M
crystalline species with different internal lattice.

SA
 The crystal form of sulphacetamide is Orthorhombic.

 Molecules in the Smectic liquid crystals are characterized by Mobility in two directions
and rotation in one axis.

Gpat Discussion Center Pvt. Ltd. |  www.gdclive.com, www.gdconlinetest.in |  gdcgpat037@gmail.com | 8602227444, 9770765680
ALLAHABAD | BILASPUR | BHILAI | RAIPUR | LATUR | BHOPAL | INDORE | PUNE | NASHIK | DELHI | GHAZIABAD | BHUBANESWAR | BRAHMAPUR | MUMBAI
7
o Rotating cylinder method

o Tilted box method
 Scale of flowability
SP
TI
ER
G
N
FI
B. Carr’s consolidation index (Compressibility):-
R
 In a free-flowing powder, the bulk density and tapped density would be close in
value, therefore, the carr’s index would be small. U
YO
Carr’s index = × 100
AT
 Scale of compressibility
HAUSNER RATIO FLOW CHARACTER COMPRESSIBILITY INDEX
1.0 – 1.11 Excellent  10
T
1.12 – 1.18 Good 11-15

PA
1.19 – 1.25 Fair 16-20

1.26 – 1.34 Passable 21-25
G
1.35 – 1.45 Poor 26-31

1.46 – 1.59 Very poor 32-37
F
>1.60 Very- very poor  38

PD
C. Dispersibility :- The ability of a material to flow or pour easily over a plane.

E
Dispersibility (%) = × 100

PL
D. Hausner’s ratio :-
M
Hausner’s ratio =
SA
 NOTE
 Bulkiness is
 The reciprocal of bulk density is bulkiness.
 Bulkiest substance will require container larger than required for less bulky
substance
 Bulkiness increases with decrease in particle size

15
P S
 ADSORPTION
TI
 Adsorption is the adhesion of atoms, ions, or molecules from a gas, liquid, or dissolved
ER
solid to an interface.
 There are two general types of adsorptions:
G
CHEMICAL ADSORPTION OR
PHYSICAL ADSORPTION
N
CHEMISORPTION
FI
 The adsorbate is bound to the  Involves the stronger valence forces.
surface through the weak van der  Seldom revesible
R
Waals forces.  Monolayer
 Weak, reversible  Not free to move
 Multilayer U
YO
 Absorbate free to move
 ADSORPTION ISOTHERM
AT
Adsorption
 Amount of gas absorbed is plotted against isotherm
equilibrium pressure of gas at constant x

T
m
temperature.
PA
 Equations which defines adsorption isotherms

are – Freundlich, Langmuir and Brunner,
G
P PS Saturation
Emmett and Taller (BET). pressure
F
 TYPES OF ISOTHERMS
PD
S. NO. TYPES EQUATION ABBREVIATION

1. Linear Isotherm
E
2. Freundlich adsorption Log = Log k + Log p y  Mass of gas

PL
isotherm adsorbed per unit

weight of absorbent
M
k, n  Constant
SA
p  Equilibrium gas
pressure

25
GPAT DISCUSSION CENTER : MAKES STUDY EASY
P S
TI
ER
It is an order written by a physician, dentist, veterinarian or a registered medical
practitioner (RMP) to a pharmacist to compound and dispense a specific drug for the
G
patient
N
The word “prescription” is derived from the Latin term praescriptus. (Prae - ‘before’ and
FI
scribere - meaning ‘to write’).
 PARTS OF PRESCRIPTION
R
Superscription • It is represented by RX (Latin U
YO
(Symbol Rx) term) “recipe” which means
‘‘take thou” or “you take”.
• In olden days, the symbol was
AT
considered to be originated from

the sign of Jupiter.
• Jupiter is the Greek God of
T
healing.
PA
Inscription • It is the main part of the

(Medication prescription.
G
prescribed) • It contains the names and

quantities of the prescribed
F
medicaments.
PD
Subscription • In this part the prescriber gives

(Direction to direction to the pharmacist
Pharmacist)
E
regarding the dosage form to be

prepared.
PL
Signatura • To be placed on the label.

(Direction for • It is usually written as “Sig”
M
Patient) • The signatura written in English

SA
and use some Latin abbreviations

like t.i.d (thrice a day), b.i.d (twice
a day) and o.d (once a day).

42 Gpat Discussion Center Pvt. Ltd. |  www.gdclive.com, www.gdconlinetest.in |  gdcgpat037@gmail.com | 8602227444, 9770765680
S
HOSPITAL - A hospital is a health care institution
P
providing patient treatment with specialized
TI
health science and auxiliary healthcare staff and
ER
medical equipment.
G
N
 CLASSIFICATION OF HOSPITALS
FI
Type I. On Clinical Basis & Ownership and control basis
CLINICAL-BASIS NON-CLINICAL-BASIS
R
Medicine Surgery Maternity Governmental Non-Governmental
1. Paediatrics 1. Orthopaedic 1. Short-U • Army Private Hospitals
YO
2. Psychiatric 2. Gynecology term hospital for Profit
and Nervous 3. ENT. 2. Long- • Navy hospital Non-Profit Church
diseases term • City hospital hospital
AT
3. T.B. Hospital • Civil hospital Community hospital

4. General • Big hospitals Missionary hospital
T
medicine • AIIMS/PGI Charitable hospital

PA
etc.
Type II – On size basis
G
Large Hospitals Beds 1000 and above

F
Medium Hospitals Beds between 500 – 1000

PD
Small Hospitals Beds between 100 – 500

Very small Hospitals Beds less than 100
E
 FLOOR SPACE REQUIREMENT

PL
S.N. AREA SQ. FT. FOR 50 BEDS 100 BEDS 200 BEDS
1. Compounding and dispensing 205 320 495
M
laboratory
SA
2. Parenteral solutions laboratory 185 200

3. Store Room 125 200
4. Manufacturing laboratory 120
5. Office and Library 105
6. Circulation 60
7 TOTAL 205 630 1,180

P S
TI
ER
 Flow of fluids is the flow of substance (liquids and gases) that does not permanently
resist distortion.
G
 Fluid mechanics is divided into Fluid statics and Fluid dynamics.
N
 Fluid statics deals with fluids at rest in equilibrium.
FI
 It is employed in the working of manometers.
 It is also applied for quantification of fluid flow as in Bernoulli’s theorem.
R
 Fluid dynamics deals with fluids in motion.
 Manufacture of dosage form U
YO
 Handling of drugs for administration
 MANOMETER
AT
 Manometers are the devices used for measuring the pressure difference.
 Different types of manometers
T
PA
DIFFERENTIAL
SIMPLE MANOMETER INCLINED MANOMETER
MANOMETER
 It is a device which  It is a manometer which  It is a device which
G
measures pressure at a measure the difference measures the minute

point in a fluid contained of pressure between pressure differences
F
in a pipe or vessel. any two points in a pipe between any two points
PD
 U tube fluid manometer or vessel containing in a fluid contained in a

fluid. pipe or vessel.
 Two-fluid U-tube
E
manometer
PL
USES USES USES

 Used in measuring the  Useful for measuring This type of manometer
M
consumption of gases in even small gas pressures increases the accuracy of

SA
chemical reactions.  Used in measurement of the pressure determination

 Used in conjunction with small pressure of particularly for small
flow meters for differences. head.
measurement of flow of
fluids

PHARMACEUTICS : PHARMACEUTICAL ENGINEERING
 EVAPORATION EQUIPMENTS
EVAPORATOR USES
Evaporating pan It contain liner as pan and use for aqueous and thermo-
(Steam jacketed kettle ) stat liquor.
Vacuum pan Use for thermolabile materials.
Evaporating stills Use for thermolabile materials.
S
Horizontal Tube Use for liquor that do not crystallize and not form scale
P
Evaporator and non-viscous.
TI
Vertical tube Evaporator Use in sugar industry, concentrate cascara extract and not
(CALANDRIA) for foamy liquid.
ER
Vertical tube Use for sugar, salts and heavy chemical.
(Basket type) evaporator
G
Climbing film • Use for Insulin, Vitamin Blood plasma, Liver extract like
(Kestner Tube) thermolabile material and for foamy corrosive liquid.
N
Evaporator • Not for viscous liquids.
FI
R
U
YO
 Distillation is defined as the separation of the components of a liquid mixture by a
process involving vaporization and subsequent condensation at another place.
AT
 Jabir ibn Hayyan is discovered distillation.

T
Thermometer Cold water in

PA
Condenser
G
Distillation
adapter
F
PD
Fractionating
column
E
Cork
Water out
PL
Distilling
flask
M
SA
Vapor Receiving flask
Distillate
Burner

101
PHARMACEUTICS : PHARMACEUTICAL TECHNOLOGY
SP
TI
ER
 This is an investigation of physical and chemical properties of drug substance alone and
when combined with excipients.
G
 OBJECTIVE
N
 To formulate an elegant, safe, efficacious dosage form with good bioavailability.
FI
 To formulate new dosage form of an already existing drug.
 Determination of all the properties of drug and the best suitable dosage form for the
R
drug molecule.
CHARACTERISTICS OF DRUG U
YO
PHYSICAL CHEMICAL ORGANOLEPTIC

AT
CHARACTERISTICS CHARACTERISTICS CHARACTERISTICS
Bulk characteristics Oxidation & Reduction Colour

T
Solubility analysis Photolysis Odour

PA
Stability analysis Polymerization Taste

G
Decarboxylation
Hydrolysis
F
PD
Racemization
Isomerization
E
Enzyme decomposition
PL
M
SA
Preformulation Studies
Final Product
Raw materials

ALLAHABAD | BILASPUR | BHILAI | RAIPUR | LATUR | BHOPAL | INDORE | PUNE | NASHIK | DELHI | GHAZIABAD | BHUBANESWAR | BRAHMAPUR | MUMBAI 113
FACTORS AFFECTING STABILITY OF DRUG
INTERNAL FACTORS FORMULATION ENVIRONMENTAL

FACTORS FACTORS
 Chemical structure
 Excipient
 Impurity  Light and oxygen
S
 Drug : Excipient ratio
 Physical form  Temperature
 Processing method
P
 Moisture content  Humidity
 Particle size  Packaging material
TI
 Morphology
ER
 BIOPHARMACEUTICAL CLASSIFICATION OF DRUGS
 Proposed by G.L. Amidon
G
 Maximum drugs falls under BCS class-II and IV
N
CLASS SOLUBILITY PERMEABILITY ABSORPTION EXAMPLE
FI
I High High Well absorbed Diltiazem,
Propranolol,
R
Metoprolol
II Low High U Variable Nifedipine,
Carbamazepine,
YO
Naproxen
III High Low Variable Insulin, Metformin,
Cimetidine
AT
IV Low Low Poorly Taxol, Chlorothiazide,

Absorbed Furosemide
T
PA
G
 SOLID DOSAGE FORM

F
SOLID DOSAGE FORM

PD
BULK
UNIT DOSAGE FORM
E
PL
INTERNAL
POWDER TABLETS CAPSULES CACHETS
M
 Soluble Tablets  Hard gelatin  Dry seal Fine powders Granules

 Soft gelatin  Wet seal
 Effervescent tablets
SA
 Lozenges tablets
 Sugar coated Effervescent Non - Effervescent
 Chewable tablets  Film coated
 Buccal tablets  Compression coated
 Hypodermic tablets  Enteric coated
EXTERNAL
 Sublingual tablets
Dusting powder Insufflation Dental powder

(Dentifrices)

SUSPENSION
 Dispersions where Active Pharmaceutical Ingredient of low solubility is dispersed in

the external phase. Particle size range is usually greater than 0.1µm.
S
• Suspension
BASED ON PHYSICAL
• Aerosols
P
STATE
• Foams
TI
• Dilute suspension (2 to10% w/v
solid). e.g.: - cortisone acetate,
ER
BASED ON prednisolone acetate.
PROPORTION OF • Concentrated suspension (50%w/v
SOLID PARTICLES solid). e.g.: - zinc oxide suspension.
G
• Molecular Dispersion (Particle size is
N
BASED ON SIZE OF less than 1 nm)
CLASSIFICATION
FI
DISPERSED • Colloidal Dispersion (Particle size
OF PARTICLES between 0.1-0.2 µm)
SUSPENSION • Coarse Dispersion (Particle size is
R
greater than 0.2 µm)
BASED ON
ELECTROKINETIC
U • Flocculated Suspension
YO
• Deflocculated Suspension
NATURE OF SOLID
PARTICLE
• Oral suspension (Paracetamol
suspension)
AT
• Topical suspension (Calamine Lotion)

BASED ON ROUTE OF
• Parenteral suspension (Solid Contents is
ADMINISTRATION
between 0.5-5% w/v. e.g.:-Procaine
penicillin G suspension)
T
 TERMINOLOGY RELATED WITH SUSPENSION

PA
TERMS DEFINITION
G
Swamping Increase in concentration of ions in the solution decrease the

thickness of double layer and therefore aggregation occur
F
Subsidence Describe the settling of an aggregated system (flocculated system)

PD
Ostwald Cyclization changes in temperature in suspension to form crystal

ripening bridging called Ostwald ripening
Freeze thaw Technique is particularly applicable to stressing suspension for
E
cycling stability testing purpose

PL
Levigation Particle size reduction by grinding

Pulverization Process of powdering by a Micronization technique
M
 DIFFERENT BETWEEN FLOCCULATED & DEFLOCCULATED SUSPENSION

SA
FLOCCULATED SUSPENSION DEFLOCCULATED SUSPENSION

Particles settles as flocs Particles settles as a separately due to low
particle size
Supernatant liquid is clear Supernatant liquid is cloudy
Suspending agent settles down Suspending agent remains suspended for
rapidly long time

 MANUFACTURING OF TABLETS
Wet granulation
Granulation & Dry granulation

Compression
Tablet (Compression
manufacturing granulations)
S
Direct Compression 1. Slugging
P
2. Roller compression
TI
 Granulation :- Granulation process transforms fine powders into free-flowing,
ER
dust-free granules that are easy to compress. It is one of the most significant unit
operations in the production of mostly tablets and capsules.
G
 Compression :- During the compression stage, the top and bottom punch come together
N
by pressure within the die to form the tablet. After that top and bottom punches move
FI
between two large wheels called compression rolls.
R
 Wet granulation :- In wet granulation the API and excipients are mixed with water or
U
an organic solvent to make a dumb mass and then sieved into its fine granules.
YO
 Dry granulation :- Done when drug in sensitive to heat and moisture. eg - Aspirin,
Vitamin. This process doesn’t contains any liquid solvent for mixing.
AT
T
PA
G
F
PD
E
PL
M
SA

 STEPS OF SUGAR COATING
STEPS OF
SUGAR COATING
1. Seal/Sugar Coating 2. Sub coating 3. Smoothing 5. Polishing
P S
To prevent moisture Round the edges and build Cover and fill imperfection Provide desired
penetration into the up the tablet size (↑se in the tablet surface luster on the
TI
tablet core. tablet weight 50-100 %). caused by sub coating surface of tablet.
E.g., Zein, Shellac E.g., Sticky Binder: Gelatin, step. Colorants are added E.g., Wax (Beeswax
ER
Acacia in this step. or Carnauba)
4. Color coating 6. Printing
G
N
To impart and Printing on the surface of
elegancy and tablet is done by
FI
uniform color. rotogravure. To facilitate
identification with
manufacturer’s logo or code
R
 COMPONENTS OF FILM COATING
U
YO
COMPONENTS OF FILM COATING
Film former Solvents Opaquant-extenders

AT
Enteric materials Non-enteric materials • Water • Titanium dioxide

• Ethanol • Silicates (talc, aluminum
• Cellulose Acetate • HPMC
• Methanol silicate)
T
Phthalate • Methyl Hydroxyethyl cellulose

• Acrylate Polymers • Isopropanol • Carbonates (magnesium
• Ethyl cellulose
PA
• Chloroform carbonate)
(Eudragit L and S) • Hydroxy propyl cellulose
• Acetone • Sulfates (calcium sulfate)
• Hydroxypropyl • Povidone
• Methyl ethyl • Oxides (magnesium oxide)
Methylcellulose Phthalate • Sodium CMC
G
ketone • Hydroxides (aluminum

• Polyvinyl Acetate • Polyethylene Glycols
• Methylene chloride hydroxide
Phthalate • Acrylate Polymers (Eudragit)
F
PD
Miscellaneous Coating Solution Colorants Plasticizers
• Flavours • Inorganic materials (e.g., Iron oxides) • Castor oil

• Sweetener • Natural coloring materials (e.g., • Propylene glycol
E
• Surfactants Anthocyanins, Caramel, Carotenoids, • Glycerin

• Antioxidants Chlorophyll, Indigo, Flavones, • Polyethylene glycols
PL
• Antimicrobials Turmeric, and Carminic acid) of 200 and 400 series
 TERMS RELATED WITH TABLET COATING

M
SA
TERMS DEFINITION
Opalux Opaquant colour concentrate for sugar coating
Opaspray Opaquant colour concentrate for film coating.
Opadry Complete film coating concentrate

 TYPES OF FILM DEFECTS
SP
TI
ER
G
N
FI
R
U
YO
 EVALUATION OF TABLET
AT
T
PA
G
F
 NON OFFICIAL TEST

PD
1. HARDNESS
 Tablets require a certain amount of strength, or hardness and resistance to
E
friability, to withstand mechanical shocks of handling in manufacture, packing

PL
and shipping
M
HARDNESS TESTER COMMENTS

Monsanto Tester Gives strength in Kgs
SA
Strong-cobb Tester Force applied by hydraulic pressure & later air Pressure
PfizerTester Force applied by hydraulic pressure & later air Pressure
ErwekaTester Gives strength in Kgs.
Schleuniger Tester Gives strength in Kgs & strong cobb.
Vickers Used to measure the surface hardness.
Webster & Van Abbe Indicated edge damage during handling.

 TRICK TO REMEMBER DISSOLUTION APPARATUS
P S
TI
ER
G
N
FI
R
U
YO
Solid Dosage CAPSULES Drug Enclosed Hard or soft
Forms substance soluble shell
Formed by
AT
Acid-bone gelatin
Isoelectric point pH 5.5–6.0 GELATIN
T
Hard gelatin Soft gelatin Type A Type B

PA
capsule capsule
Source : Pork Source: Green
skin (fresh) bone
G
Acid treated Alkali treated

F
precursor precursor
PD
Isoelectric point Isoelectric point

pH - 9 pH - 4.7
E
 DIFFERENCE BETWEEN HARD & SOFT GELATIN CAPSULES

PL
CRITERIA HARD GELATIN CAPSULES SOFT GELATIN CAPSULES

M
Shell Not plasticized Plasticized (Glycerin, Sorbitol, PEG)

SA
Moisture 12-16% 6-10%

Sizes Limited Many
Shapes Two-piece One-piece
Content Usually dry solids Usually liquids or suspensions
Traditional friction-fit,
Closure Hermetically sealed (Inherent)
mechanical interlock, banding

 MANUFACTURING OF HGCs INVOLVE FOLLOWING COMPONENTS
MANUFACTURING OF HARD GELATIN CAPSULES (HGCs)
Formulation of shell Production of shell Formulation of filling material Filling of capsule
S
Gelatin or its Gelatin is heterogeneous product derived by hydrolytic extraction of animal’s
P
substituent collage eg- Type A gelatin and Type B gelatin
TI
Water soluble dyes: Azo dyes (having an -N-N- linkage) and non-azo (eg-
Colorants erythrosine, indigo carmine, quinoline yellow)
ER
Insoluble pigments: eg-. iron oxides- black, red and yellow.
G
Opaquing agent Used to make the capsule opaque eg- Titanium dioxide (TiO2)
N
FI
Plasticizers Used to increase the elasticity of capsule shell eg- Sorbitol, Glycerine, PEG
R
Applied to prevent microbial contamination methyl paraben and Propyl
Preservatives
paraben (4:1)
U
YO
Wetting agent 0.15% w/w of sodium lauryl sulphate, to ensure that the lubricated metal
moulds are uniformly covered when dipped into the gelatin solution.
AT
 METHODS OF MANUFACTURING EMPTY GELATIN CAPSULE SHELLS

T
STEPS DESCRIPTION
PA
Temperature of pins = 22° C, Solution temperature = 50° C

Dipping
Time required = 12 seconds
G
Pins are rotated to distribute the gelatin uniformly around

Spinning
F
the pins
PD
Drying By use of dry air and dehumidification

Stripping By bronze jaws
E
Trimming By stationary knives

PL
Joining Cap and body are joined

M
Polishing Polishing by the polymer

SA
Preliminary Gelatin Dipping & Cutting Cutting Printing Testing Inspection Packaging
Blending
Inspection Melting Removing

 Microencapsulation is the method of applying a thin film or coating to small particles of

solids or droplets of liquids or and dispersion.
 Approximate particle size: 1 – 5000 microns
P S
TI
ER
G
N
FI
R
U
YO
 FORMULATION OF MICROENCAPSULATION
MICROENCAPSULATION FORMULATION
AT
Core material Coating material

T
Waxes Enteric
Water soluble Water insoluble
and lipids coating
PA
1. Acetaminophen 1. Gelatin 1. Ethyl Cellulose 1. Paraffin 1. Shellac

2. Aspirin 2. Starch 2. Polyethylene 2. Carnauba 2. Zein
G
3. Isosorbide dinitrate 3. PVP 3. Polymethacrylate 3. Spermaceti 3. Cellulose

4. Potassium chloride 4. Arabinogalactan 4. Polyamide (Nylon) 4. Beeswax acetate
5. Progesterone 5. Polyvinyl alcohol 5. Cellulose Nitrate 5. Stearic acid phthalate
F
6. Vitamin A palmitate 6. Polyacrylic acid

PD
7. Carboxy-methyl cellulose
8. Hydroxyethyl cellulose
 TECHNIQUES OF MICROENCAPSULATION
E
S.NO. TECHNIQUES USED METHODS

PL
• Coacervation phase separation

1.
Physicochemical • Sol- Gel encapsulation coacervation
•
M
method Layer-by-layer assembly

• Solvent evaporation
SA
• Pan coating
Physicomechanical
• Air suspension method
2.
method
• Spray drying
• Multiorifice
• Spray congealing Dip coating
3. Chemical method
• Polymerization Complexation
• In situ polymerization

 CLASSIFICATION OF STERILIZATION METHOD
Sterilization
Physical Chemical Mechanical
S
Gas
P
- Formaldehyde Filteration
Sunlight Vibration - Ethylene oxide - Membrane filter
TI
Heat Radiation
- -propiolactone - Seitz filter
Ionization - Ozone
ER
- Shintered glass
Dry Heat Moist heat - X-ray filter
-Inceneration Temperature - Gamma rays Liquid - Candle filter
-Hot air oven below 100oC - Alcohol
G
-Flaming Steam Non Ionization - Aldehydes
-Red Heat - Phenolics MSC
N
Pasteurization - IR ionization
- UV rays - Halogens
Inspissation - Heavy Metals
FI
Temperature - Surfactants
- Dyes
Computer
at 100oC
R
Tyndalization
AAP HaiH
Boiling
Temperature
U
YO
above 100oC Super
Autoclave
Dad
AT
 HEAT STERILIZATION
T
PA
Sterilization by heat is of two types:-

A) Dry heat - Killing effect is due to protein denaturation, oxidative damage and the toxic
effect of elevated metabolites.
G
Method used are:-

F
1. Incineration:-It is used for contaminated clothes, animal carcasses and pathological

PD
materials.
2. Hot air oven:-It is used for glassware, all glass syringes, swabs, liquid paraffin,
dusting powder forceps, scissors, scalpels, fat and grease.
E
Holding time
PL
Method Temperature (0C)

(in minutes)
Hot air 170 60
M
oven 160 120

SA
150 150
140 180
3. Flaming :- Involves exposure of metallic objects to flame for some time where the
flame burns microbes and other dust presents in the instrument.
4. Red Heat :- Red heat sterilization is the process of instant sterilization by holding the
instruments in a Bunsen flame till they become red hot.

 TYPES OF PARENTERAL PREPARATION
P S
TI
ER
G
 CLASSIFICATION OF PARENTERAL PREPARATION
N
Small volume
FI
parenteral (SVP): max
vol. up to 100 ml
Based on volume
R
Large volume
U parenteral (LVP): max
vol. >100 ml
YO
Single dose ( no need
PARENTERAL of preservative )
PREPARATIONS Based on type of
AT
packaging
Multidose (up to 30 ml
)contain preservative
T
PA
Based on physical Solution, Powder,

state Suspension, Emulsion
G
PARAMETER SVP LVP

1. Volume 100ml or less 101-1000 ml
F
2. Route IV, IM & SC IV & Non-IV

PD
3. Dosage unit Single or multiple Single

4. Preservative & buffer Used Not used
5. Isotonicity & Pyrogenecity Not essential Essential
E
PL
 CHARACTERISTICS OF PARENTERALS
CHARACTERISTIC DESCRIPTIONS
M
1. Sterility • Dosage forms administered parenterally, ophthalmic solutions

SA
and any medical devices used in conjugation with must be

sterilized.
2. Freedom from • Freedom from particulate matter (mobile, undissolved
particulate substances).
matter • Environmental control by the use of HEPA filters,
precautions should be taken by the manufacturing
personnel.

 QUALITY CONTROL TESTING
QUALITY CONTROL TESTING
Raw material In-process Packaging &

Finished product
& component quality testing labelling
testing
testing control
P S
Environmental
& microbial Leaker Clarity Pyrogen Sterility
TI
control test test test test
Testing of
ER
glass, plastic
& rubber • Methylene • LAL test
blue test • Rabbit test
Spark test
G
•
• Hammer test
N
 Quality control testing of parenteral products
FI
• Methylene Blue Test (for ampoules)
R
Leaker test 1% Methylene blue dye and vacuum used.
(Packaging
integrity
• Hammer Test (for vials & bottles) U
YO
Presence of vacuum is detected by striking base of
test)
bottle sharply to produce water hammer sound.
Instrument used-
AT
 Light scattering (Nephelometer)

Clarity test  Light absorption, Electrical resistance
T
(Particulat (Coulter counter)

PA
e matter I.V. fluid meet the requirement- NMT 50 particle

test)
per ml of 10 µm and NMT 5 particle per ml of size
G
25 µm. (USP standard for Large volume preparations)

F
Sterility testing is performed for detecting microorganism in parenteral

PD
product. Place parenteral product in culture media

 Method
1. Direct transfer method (Thioglycolate culture media)
E
 Is used for identification of aerobic and anaerobic bacteria.

PL
 Soybean casein Culture media - Used for identification of fungi.

Sterility
2. Membrane filtration technique
M
test
 It is suitable for liquids, soluble powder with bacteriostatic or
SA
fungistatic oils, creams, and ointment.

 It is done by passing the products from membrane filter with porosity
of 0.45 mm with diameter 47mm with flow rate of 55-75 ml/per
min. at a pressure 70 cm of mercury .

 Ophthalmic preparations are sterile

lens sclera
preparations, designed to be instilled
iris retina
on to the external surface of the eye choroid
S
vitreous chamber
(topical), administered inside cornea
P
vitreous humor
(intraocular) or adjacent to the eye fovea
TI
(periocular).
ER
 These products must be isotonic with
lachrymal secretions to avoid
discomfort and irritation. The pH
G
should be controlled up to 7.4 to anterior chamber
N
optic nerve
avoid irritation. aqueous humor
FI
 Ocular dosage forms shows poor suspensory ligaments
bioavailability (< 1%) of drugs mainly due to the precorneal loss factors.
R
 TYPES OF OPHTHALMIC PREPARATION
U
YO
TYPES OF OPHTHALMIC PREPARATIONS
AT
Solution Suspension Ointment

T
To produce the Should not contain

PA
These are prepared

desire therapeutic particle size larger
under aseptic
effect. Care must be enough to produce
eye irritation condition and
taken that solution
(>10μ). packed in sterile
G
remain in the eye.

collapsible tubes.
Contact lens
F
care solution Eye lotion Ophthalmic

insert
PD
Facilitate the Drug is dissolved in a Sterile preparation

care of contact non-aqueous vehicle, containing solids or
lenses to make such castor oil, and
E
semisolids, whose
them wearable. emulsified with size and shape are
water using a
PL
especially design to
nonionic surfactant. increase ocular
residence, possibility
M
of releasing drugs.
SA

 ACTUATORS
 Used to ensure that the aerosol product is delivered in
the proper and desired form.
 TYPES OF AEROSOL SYSTEMS
S
Two phase system, active ingredient is soluble in the propellant, cosolvents such
P
Solution system as ethanol or isopropanol may be used, propellant added for foam system is
TI
usually 5% and for inhalation 95% is required.
ER
Three phase system (propellant phase, water phase and vapor phase),used to
Water based
emit formulation as spray or foam, cosolvent ( ethanol) or surfactants ( long
system chain fatty acids esters of polyhydroxylic compounds,0.5-2%)are used.
G
Three phase system, difficult to formulate, physical stability of the system can be
Suspension or
N
increased by the control of moisture content ,reduction of partical size of 5μ( 50
Dispersion for topical),adjustment of density of propellants and /or suspension, use of
FI
system dispersing agents.
R
Consist active ingredient, aqueous or nonaqueous Vehicles, surfactants,
Foam system propellants. Produce quick stable or quick breaking foam. The liquefied
U
propellant is emulsified and is generally found in the internal phase.
YO
AT
Aqueous stable Non-aqueous Quick breaking Thermal foam

foam stable foam foam Produce warm
Stable foam, lower Use various glycols Mainly used for foam for shaving
propellant conc. (polyethylene topical medication, (not in use)
(5%) required. glycol)
T
PA
 EVALUATION OF PHARMACEUTICAL AEROSOLS

G
 All aerosol products that are shipped in interstate commerce are subject to the
regulations of the DOT (Department of Transportation).
F
 These regulations impose limitations on the pressure within the container, flash
PD
points, flame extension, and flammability.

S NO. PARAMETER DETERMINE BY
E
FLAMMABILITY AND COMBUSTIBILITY

PL
Product is chilled to -25° F and transferred to the test

apparatus. The temp. of the test liquid is increases slowly
1. Flash Point
M
till its vapors ignite. This temp. is taken as flash point.

SA
Apparatus: Standard Tag open cup apparatus

Indicate the effect of an aerosol on the extension of an
Flame open flame. For that product is sprayed for about 4 second
2.
projection in to a flame, the flame is extended and length can be
measured by ruler.

PHYSIOCHEMICAL CHARACTERISTICS
Vapour Measured by pressure gauge and use of water bath
3.
pressure
4. Density Measured by Pycnometer or Hydrometer
5. Moisture Measured by Karl Fischer or Gas chromatography
Identification Gas chromatography or Infrared Spectroscopy
6.
of propellants
S
PERFORMANCE
P
Determined by taking known weight and discharging the
TI
contents for given period of time using standard apparatus.
ER
To determine the magnitude of the valve delivery-
Aerosol valve Valve acceptance: The test procedure applies to two
7.
discharge rate categories of metered aerosol valves having the following
G
limits. For valves delivering:
N
54 μl or less, the limits are ± 15%.
FI
55 to 200 μl, the limits are ± 10%.
This method is based on the impingement of spray on a
R
8. Spray pattern piece of paper that has been treated with a dye-talc
mixture.
U
Determined by the weighing empty container and
YO
9. Net content
reweighing after filling the container.
10. Foam stability Visual evaluations and use rotational viscometer
1. Optical microscope
AT
Particles size 2. Cascade impactor

11.
determination 3. Light scattering method
T
4. Gamma scintigraphy
PA
G
F
PD
PACKAGING
E
Primary Secondary Tertiary

PL
Material that first envelops the It is used for bulk handling,

product and holds it. Examples: warehouse storage and transport
M
Ampoules, Vials, Containers, Dosing shipping. The most common form is

dropper, Closures, Syringe, Strip & a palletized unit load that packs
SA
Blister packaging. tightly into containers.
It is outside the primary packaging -

and used to group primary
packages together Example: Paper
and boards, Cartons, Corrugated
fibres, Box.

Multivesicular vesicles
(Vesosomes)
P S
TI
ER
 NIOSOMES
G
 Non-ionic surfactant vesicles (niosomes or NSVs).
N
Niosomes are promising vehicle for drug delivery.
FI
 Niosome are non-ionic surfactant vesicle +
R
Cholesterol or other lipids.
 Niosome have better stability than liposome. U
YO
 Their physical properties are similar to liposomes.
 NANOPARTICLE
AT
 Nanoparticles are defined as particulate

dispersion, or solid particles having the size range
10- 1000 nm.
T
 Biocompatible, Biodegradable, offer complete drug

PA
protection.
 Nanospheres – Polymeric matrix
G
 Nano capsules – Drug encapsulated in a shell

F
 MICROSPHERES
PD
 Microsphere are small spherical particles, with diameters

in the micrometer range {Typically 1 mm to 1000 mm
E
(1 mm)}.
PL
 Microspheres are sometimes referred to as

microparticles.
M
 Drug is dispersed in polymeric matrix.

SA
 RESEALED ERYTHROCYTES
 Prepared by dipping RBCs in hypotonic media which leads to rupturing of cell
membrane and formation of small pores.
 When RBCs are again placed in an isotonic media at 37°C resealing of membrane
takesplace with drugs.

PHARMACEUTICS : BIOPHARMACEUTICS
S
Biopharmaceutics is defined as the study of factors influencing the rate and amount of drug
P
that reaches the systemic circulation and the use of this information to optimize
TI
therapeutic efficacy of drug products.
ER
G
N
FI
The term “Pharmacokinetics” is derived from Greek words Pharmakon (drug) and Kinesis
(movement). It is the
R
quantitative study of drug
movement into through and
out of the body and their
U
YO
relationship with the
p h a r m a c o lo g i c a l,
AT
therapeutic or
toxicological response
in man or animals. The
T
frequency of administration
PA
of a drug in a particular dose

is called Dose regimen.
G
F
PD
E
PL
M
SA

185
ABSORPTION
 THE BASIC STRUCTURE OF FUNCTIONAL CELL MEMBRANE
P S
TI
ER
G
N
FI
R
 MECHANISM OF ABSORPTION
U
1. TRANSCELLULAR / INTRACELLULAR – MOST COMMON PATHWAY FOR DRUG
YO
TRANSPORT
AT
T
PA
G
F
PD
E
PL
M
SA

PHARMACEUTICS : BIOPHARMACEUTICS
• Highly specilized Pericyte,

Astrocyte and Capillary
endothelium
• Less permeable to water
soluble drug
• Allows highly lipid soluble
S
unionized drugs.
• Approach for improve
P
Blood brain
TI
barrier penetration of drug through
BBB
ER
 Used as penetration enhancer –
Dimethyl sulphoxide (DMSO)
G
 Osmotic disruption by using –
Mannitol
N
 Using drug carrier –
FI
Dihydropyridine redox
• Barrier located at sertoli cell
R
junction.
Blood testis U
YO
barrier
AT
• CSF formed from choroid

plexus.
• Highly lipid soluble drugs can
T
cross through barrier

PA
Blood
cerebrospinal • Sulphamethaxazole and
fluid barrier Trimethoprim
G
F
PD
• Drugs having molecular weight

< 1000 daltons
•
E
Highly lipid solubility.

PL
Blood eg – Ethanol, Sulphonamide,

placental Cross by endocytosis –
barrier immunoglobulin
M
• Cross by carrier mediated

SA
transport – Essential nutrients

for fetal growth

195
PHARMACEUTICS : PHARMACEUTICAL JURISPRUDENCE
SP
TI
ER
 INTRODUCTION TO JURISPRUDENCE
G
TERMS DESCRIPTION
N
The study of fundamental legal principles and is also science
JURISPRUDENCE
FI
and philosophy of law.
Ethics is the science of human conduct. With reference to the
R
ETHICS human conduct there is the ideal moral code and the positive
moral code.
LAW
Rules of human conduct binding on all person in a state or U
YO
nation.
It is a branch of pharmacy which deals with the knowledge of
PHARMACEUTICAL
laws relating to drugs and pharmaceuticals and about
JURISPRUDENCE
AT
pharmacy profession.
 HEALTH SURVEY AND DEVELOPMENT COMMITTEES

T
PA
COMMITTEES DESCRIPTION CHAIRMANSHIP

 Oct. 1943 - Health Survey and
G
BHORE Development Committee by Sir Joseph

COMMITTEE Govt. of India William Bhore
F
PD
 In 1953 - Pharmaceutical
BHATIA Enquiry Committee by Major General
Government of India
E
COMMITTEE S. L. Bhatia
PL
 June 1959 - Health Survey and

M
MUDALIAR Planning Committee by Govt. of Dr. A. Lakshman

COMMITTEE India swami Mudaliar
SA
 8th February 1974 – Drug and

Pharmaceutical Industry by
HATHI Jaisukhlal
Govt. of India
COMMITTEE Hathi

209
PHARMACEUTICS : PHARMACEUTICAL JURISPRUDENCE
Thane Central Drugs Testing Laboratory

Noida National Institute of biologicals
Coonoor Pasteur Research Institute
National Centre for Biological Sciences (NCBS)
Bangalore
National institute of Unani medicines
P S
TI
ER
P
H Pharmacy act governs the practice of
G
A pharmacy in India.
Came
N
R Act into force
M passed Making rights medicaments available to the
FI
4 March
A 1948 public is the primary obligation of pharmacy
1948 in order to safeguard the public health.
C
R
Y Amendment
A
1959, 1976, U
The objective of the Pharmacy act 1948 is to
regulate profession of pharmacy.
YO
1981
C
T
AT
 CHAPTERS AND SECTIONS

T
CHAPTERS DESCRIPTION SECTIONS

PA
Chapter I Introduction [1-2]

Chapter II Pharmacy Council of India (PCI) [3-18]
G
Chapter III State pharmacy councils [19-28]

(SPC)
F
Chapter IV Registration of Pharmacists [29-40]

PD
Chapter V Miscellaneous [41-46]
 SECTIONS
E
PL
SECTIONS DESCRIPTION SECTIONS DESCRIPTION

Central council Section 16 Inspection (PCI)
Section 3
M
constituted State council

University Grants Section 19
SA
Section 4 constituted
Commission (UGC) Interstate agreement
Section 20
Section 10 Education Regulations
Section 26A Inspection (SPC)
Approved courses of
Section 12 Section 36 Removal from register
study and examinations
Section 14 Foreign qualification Section 46 Power to make rules
Section 15A Central Register

215
S
 INTRODUCTION
P
 The CDSCO of India is main regulatory body for regulation of
TI
pharmaceutical, medical devices and Clinical Trials.
ER
 Head office - NEW DELHI
 Functioning under the control of Directorate General of Health
G
Services, Ministry of health and family welfare Government
of India.
N
 Drugs Controller General of India [DCGI], He/she is a responsible for approval of
FI
New Drugs, Medical devices and Clinical Trials to be conducted in India.
R
 Minister of Health and Family Welfare – Dr. Mansukh Mandaviya
U
 Drugs Controller General of India - Dr. Rajeev Singh Raghuvanshi (1st Feb 2023)
YO
NOTE :- Minister of Health and Family Welfare and Drugs Controller General of India will
change in future. So, go through Google.
 ORGANIZATION OF CDSCO
AT
DRUG CONTROLLER ORGANIZATION

T
PA
Headquarter Zonal officer Sub-zonal office Laboratories Port/Air offices

G
1. North zone: 1. Bangalore 1. CDL: Kasauli 1. Ahmedabad

New 2. Chandigarh 2. Chennai Port
Ghaziabad 2. CDL: Kolkata
Delhi
F
2. South zone: 3. Jammu & 3. RDTL: 3. Chennai Airport

Kashmir Guwahati 4. Bangalore
PD
Chennai
3. East zone: 4. Goa 4. RDTL: 5. Hyderabad
Kolkata 5. Varanasi Chandigarh 6. Goa
4. West zone: 6. Indore 5. CDTL: Mumbai 7. Kochi
E
Mumbai 7. Guwahati 6. CDTL: Chennai 8. Delhi

PL
5. Hyderabad zone 8. Baddi 7. CDTL: 9. Kolkata Port

6. Ahmedabad zone (Himachal Hyderabad 10.Kolkata Air Cargo
Pradesh) 11.Mumbai Air Cargo
M
12.Mumbai Nhava
Sheva
SA
13.Mumbai Custom
• New drugs • GMP Audits • Testing of drug
House
• CLAA • Coordination with samples
• Imports states • Validation of test
• DTAB/DCC protocols • Import
• Export

S
2
P
TI
PART
ER
G
N
FI
R
PHARMACOLOGY U
YO
AT
T
PA
G
F
PD
E
PL
M
SA
Ä Human Anatomy & Physiology

Ä Pathophysiology
Ä Pharmacology
PHARMACOLOGY : HUMANANATOMYAND PHYSIOLOGY
Human Anatomy &

Physiology
P S
TI
ER
 CELL
 The cell is the basic unit of life, structural Cytoplasm
G
Nucleus
and functional unit of an organism.
N
Golgi
Chromosomes
 Anton von leeuwenhoek first saw and apparatus
FI
Lysosome
Centrioles
described a living cells. Nucleolus
Endoplasmic
R
 CELL THEORY reticulum Mitochondrion
 Cell theory was jointly put forward by U Ribosomes
Examples of Different Cells

Cell membrane
YO
Matthias Jakob Schleiden and Theodor Epithelial
Cell
Muscle
Cell
Nerve
Cell
Connective
Tissue Cell
Schwann in 1839.
AT
 Rudolf Virchow (1855) first explained

that cells divide and new cells are formed
from pre-existing cells.
T
PA
 TYPES OF CELLS
 Two types
G
(i) Prokaryotes cells (ii) Eukaryotes cells

F
 DIFFERENCE TYPES OF PROKARYOTIC AND EUKARYOTIC CELL

PD
PROKARYOTIC CELL EUKARYOTIC CELL

• • Multicellular cell
E
Single cell
• The cell size is usually small (0.1- 5 μm).
• The cell size is usually small (5-100
PL
μm).
• Cell division :- Binary fission
• Cell division :- Mitosis
• •
M
Membrane bounded cell organelles Membrane bounded cell organelles

absent. present.
SA
• Contain muramic acid • Does not Contain muramic acid

• Cell organelles are absent, EXCEPT • Cell organelles are present, Ribosomes
Ribosomes :- 70 S :- 80 S
• Pili and Fimbriae may be present • Pili and Fimbriae may be Absent
• Examples include Archaea, Bacteria & • Examples include Plants, Fungi, and
Cyanobacteria. Protozoa & Animals.

259
TYPES OF GASTRIC GLANDS
Cardiac gland Pyloric gland Fundic gland

Cardiac glands are found in the These glands are formed by G cells, Possess four types of cells: chief or peptic
Cardiac of the stomach Secrete mucus cells, EC cells and ECL cells. (zymogen) cells, oxyntic cells, goblet cells
alkaline mucus Secrete alkaline mucus and argentaffin cells
Oxyntic cells also known as parietal cells,
secrete HCI and intrinsic factor (castle's
S
intrinsic factor).
P
TI
ER
G
N
FI
R
U
YO
 SALIVARY GLANDS AND THEIR LOCATION
AT
T
PA
G
F
PD
E
PL
M
Fig : Anatomy of Salivary Glands

SA
SALIVARY SALIVARY LOCATION OF SALIVARY DUCTS

S.NO
GLANDS GLANDS DUCT ORIFICE
Parotid or Largest, below and Opens at papilla in buccal mucosa
1.
Stensen's duct Infront of ears opposite maxillary second molar
2. Submandibular Wharton’s duct Opens at Sublingual papillae
3. Sublingual Bartholin’s duct Near Submandibular duct

267
 TYPES OF JOINTS IN HUMAN BODY

JOINTS
Fixed or Cartilagenous or Freely movable or

fibrous joints slightly movable synovial joints
E.g. Bones of skulls, E.g. Between centre of 2 vertebrae,
S
Bones of pelvic girdle ribs & sternum
TYPES
P
TI
ER
Gliding joint Hinge joint Ball & Socket Pivot joint Ellipsoid joint Saddle joint
E.g. Between E.g. Elbow joint, E.g. Hip joint E.g. Between E.g. Wrist or E.g. Carpometacarpal
vertebrae, wrist & knee joint radius & Ulna radiocarpal joint of human thumb
G
ankle bone & atlas & axis joint
vertebrae
N
FI
R
U
YO
 INTRODUCTION
 Nervous system is a system of Neurons, Nerves and nervous organs that coordinate
AT
and control the activities of different parts of animal body by sending and receiving
nerve impulses.
 The functional & structural unit of nervous system is Neuron (Nerve cell).
T
PA
Nervous system
G
Central Nervous system Peripheral Nervous system

F
Spinal Cord Brain

PD
Somatic Autonomic
Nervous system Nervous system
Cervical
E
Thoracic Sympathetic Parasympathetic

PL
Nervous system Nervous system
Lumbar
Forebrain Midbrain Hindbrain
M
Coccyx
SA
Telencephalon Diencephalon Mesencephalon Metencephalon
Cerebral cortex Myelencephalon
Basal Ganglia Thalamus Medulla

Pons Cerebellum
Hippocampus
Hypothalamus
Amygdala
Cerebrum Tectum

277
Pathophysiology
S
 Four important components of pathology
P
are
TI
Pathophysiology is a
i. Etiology (causative factors)
science dealing with the
ER
ii. Pathogenesis (mechanism or process by
study of diseases.
which disease develops)
Rudolf Virchow coined the
iii. Morphology (appearance of cells, tissues
G
term 'Cellular pathology'
or organs)
N
iv. Clinical features.
FI
R
U
YO
 When the cell is exposed to an injurious agent/stress/stimulus, and it leads to injury of
the cell, it is termed Cell injury.
NORMAL CELL
AT
(Homeostasis)
T
Stress Injurious stimulus

PA
Inability to
adapt Severe, persistent stress
IRREVERSIBLE CELL INJURY
G
ADAPTATION CELL INJURY

Atrophy, Hypertrophy, Hyperplasia, Damage to cell membrane
Altered Calcium influx Nuclear changes :-
Metaplasia, Dysplasia functional Pyknosis, Karyorrhexis and Karyolysis
F
demand Mild to moderate stress (injury)

PD
Stress removed
REVERSIBLE CELL INJURY
Degenerations, Subcellular Alterations,
NORMAL CELL RESTORED Intracellular Accumulations
E
Stress removed
Necrosis Apoptosis
PL
REPAIR AND HEALING

CELL DEATH
M
 Hypoxia :- Due to decrease in oxygen supply to the cells.

SA
 Ischemia :- Ischemia is insufficient blood flow to cells or organs that to maintain their
normal function.
 The major mechanism of damage to plasma membrane in ischemia is Increased Ca++ ions
in the cytosol.
 Caseouse necrosis is a good example of Structure less necrosis.

PHARMACOLOGY
SP
TI
ER
PHARMACOLOGY - Branch of biology deals with study of drugs action on living system.
 DISCOVERIES AND THEIR SCIENTIST NAME
G
DISCOVERIES SCIENTIST
N
Father of Indian Pharmacology Ram Nath Chopra
FI
Father of Indian pharmacy education Prof. Mahadeva Lal Schroff
Father of Pharmacology Oswald Schmiedeberg
R
Father of chemotherapy Paul Ehrlich
Father of medicine Hippocrates
Founded first institute of Pharmacology U Rudolf Buchheim
YO
Discovery of Penicillin Alexander Fleming
Discovery of Streptomycin Selman Waksman
Discovery of Insulin Banting and Best
AT
Discovery of antimicrobial effect of Prontosil Gerhard Domagk

Discovery of Homeopathy Samuel Hahnemann
Discovery of Blood types Karl Landsteiner
T
Discovery of Vaccination Dr. Edward Jenner

PA
Discovery of Neurotransmitters Otto Loewi

 ORPHAN DRUG – Used for diagnosis/prevention of rare disease.
G
 Orphan drug are also called as life saving drug.

F
Trick – SR DDLj Ka FAN hai

PD
SR DDLj FAN
S  Sumatriptan, D  Digoxin antibody F  Fomipizole
Sodium stibogluconate, L  Liyothyronine (T3) A  Amphotericin B
E
Sodium thiosulfate Azacitidine

PL
R  Rifabutin, Rifaximin, N  Nitrates, Nilotinib

Rituximab
M
 ESSENTIAL DRUGS – According to WHO, drug that satisfy priority healthcare & need
SA
of majority of the population. eg - Amoxicillin, Ciprofloxacin, Metronidazole

o WHO Model List of essential drug – 1977 (First), 22nd list 2021 (Latest)  479
drugs.
o India National Essential Drug List – 1996 (First), revised in 2011, 2015 & 2022
(Latest).

317
P S
TI
ER
G
N
FI
R
U
YO
AT
T
PA
G
F
 SITES AND MECHANISMS OF ACTION OF HORMONE

PD
SITES AND MECHANISMS OF ACTION OF HORMONE

1. At cell membrane receptors
E
a) Through alteration of intracellular cAMP concentration  Adrenaline, Glucagon,

PL
TSH, FSH, LH, PTH, Calcitonin, Vasopressin (V2).

b) Through IP3/DAG generation: release of intracellular Ca2+ and protein kinase
M
activation  Vasopressin, Oxytocin

SA
c) Activation of tyrosine protein kinase  Insulin, Growth hormone, Prolactin

2. At cytoplasmic receptors:- Steroidal hormone, Mineralocorticoids, Glucocorticoids,
Androgens, Estrogen, Progestin, Calcitriol
3. At nuclear receptor: - Thyroid hormones-T3, T4, Estrogen, Vit. D, Retinoic acid.

PHARMACOLOGY
ANTIEPILEPTIC DRUGS
 INTRODUCTION
 Epilepsy is condition that causes recurrent episodes of seizures & disturbance of
S
consciousness.
P
 Lamotrigine used for depressive phase of bipolar disorder.
TI
ER
G
N
FI
R
U
YO
AT
T
PA
G
F
PD
E
PL
M
 CLASSIFICATION AND MECHANISM OF ACTION OF ANTIEPILEPTIC DRUGS

SA
S.NO. CLASS DRUGS MECHANISM OF ACTION

Phenytoin, Prolongation inactivated state of
1. Hydantoins
Fosphenytoin
voltage sensitive neuronal Na+
Carbamazepine,
2. Iminostilbenes channel that govern refractory
Oxcarbamazepine
3. Phenyltriazines Lamotrigine period of the neurone.

387
 Angiotensin I is subsequently converted to angiotensin II by the enzyme angiotensin

converting enzyme found in the lungs.
 Angiotensin II show the pharmacological actions.
P S
TI
ER
G
N
FI
R
U
YO
AT
Drugs used for Hypertension in Adverse effect of ACE inhibitors

“CAPTOPRIL”
T
Pregnancy (Better Mother Care

C = Cough (dry cough) due to increase
PA
During Hypertensive Pregnancy)

bradykinin level in the lungs.
o b-blocker
Better - B-blocker A = Angioedema (swelling of lips)
P = Proteinuria
G
o Mother - Methyldopa
T = Teratogenic effect
o Care - Clonidine O = Severe hypOtension
F
o During - Dihydropyridine P = NeutroPenia

PD
o Hypertensive - Hydralazine R = Rashes

o Pregnancy - Prazosin I = Itching
L = Loss of taste sensation (dysgeusia)
E
 IMPORTANT ONE-LINERS OF ANTIHYPERTENSIVE DRUGS

PL
 All ACE-I inhibitors drugs are prodrug except Captopril and Lisinopril.
 Arteriolar dilators are reducing after load
M
 Venous dilators are reduced preload

SA
 Moxonidine and Rilmenidine both drugs are selective for Imidazoline Receptor – that
modulate a2 receptor
 Indapamide are vasodilator used as anti-HTN in Diabetic patient.
 Most frequent side effect of ACE inhibitor is dry cough.
 The most prominent action of Angiotensin-II is vasoconstriction.
 ACE inhibitors prevent the conversion of angiotensin-I to angiotensin II.

PHARMACOLOGY
SP
TI
ER
G
N
FI
R
U
YO
 Highly ototoxic diuretic  Ethacrynic acid
 Diuretics with longest half-life  Torsemide
AT
 DOC for lithium-induced diabetes insipidus  Amiloride

 Aldosterone antagonists act at interstitial site of tubular cell whereas all other diuretics
T
act from luminal side.

PA
 Dorzolamide & Brinzolamide are used topically for glaucoma.

 Excessive use of diuretics can cause Hypovolemic shock.
G
 Metolazone is the only thiazide which is effective in severe renal failure.

F
 Hypokalemia – Reduction of serum K+ level.

PD
 Hyperkalemia – Increase of serum K+ level.

 PARTS OF NEPHRON AND THEIR MECHANISM OF WORKING
E
PARTS MECHANISM OF WORKING

PL
Part I
• Most of the filtered Na+ is actively reabsorbed (65-70%).
• Na+ K+ symport along with active reabsorption of glucose, amino-
M
(Proximal
acids, organic anions and PO4-.
Convoluted
•
SA
Carbonic anhydrase plays an important role in Na+H+ exchange and

Tubule)
helps in the reabsorption of HCO3-
• Water gets reabsorbed so tubular fluid in the PCT remains isotonic.
Part II
• Osmotic diuretics acting on this site.
(Descending
• The descending limb is impermeable to Na+ and urea and highly
permeable to water.
Loop of Henle)
• Hence fluid in the loop becomes hypertonic.

411
PHARMACOLOGY
SP
TI
ER
G
N
FI
R
U
YO
AT
T
PA
Anti-pseudomonal penicillins PENICILLIN G – DOC

“CAT-MAP” “LASTMAn”
G
o C - Carbenicillin o L - Leptospira
o T - Ticarcillin o A - Actinomyces
o S - Streptococcus, Staphylococcus
F
o M - Mezlocillin
o A - Azlocillin o T - Treponema, Tetanus
PD
o P - Piperacillin o M - Meningococcus
o A -Anthrax
E
 IMPOTANT POINTS
PL
 Penicillin G is the original Penicillin used clinically.

M
 Plasma t1/2 of penicillin G in healthy adult is 30 minutes.

 Probenecid has also been shown to decrease the Vd of Penicillin.
SA
 All MRSAs have multidrug resistance and MRSA is treated by Vancomycin (DOC).
 Vancomycin resistance staph aureus (VRSA) is treated by Linezolid or Streptogramins.
 Penicillin can cause hypersensitivity reaction.
 Allergic reaction can be diagnosed by (Scratch test)
 Intradermal test (Benzyl Penicilloyl Polylysine)

435
PHARMACOLOGY
i. Dapsone + Rifampicin + Clofazimine.

ii. Clofazimine + Ofloxacin + Clarithromycin.
iii. Rifampin + Ofloxacin + Minocycline.
ANTIFUNGAL DRUGS
S
 INTRODUCTION
P
 Amphotericin B binds the ergosterol and alter the permeability of cell membrane.
TI
 Terbinafine acts as selective non-competitive inhibitor of squalene epoxide, inhibiting
ER
synthesis of lanosterol and indirectly inhibit the biosynthesis of ergosterol.
 Itraconazole  Drug of choice for blastomycosis.
G
 Ketoconazole decreases androgen production from testis and it displaces testosterone
N
from protein binding sites.
FI
 Griseofulvin may also inhibit synthesis and polymerization of nucleic acid.
 It can also cause Disulfiram like reaction with alcohol.
R
 CLASSIFICATION OF DRUGS ON THE BASIS OF MECHANISM OF ACTION
U
YO
CLASS MECHANISM OF ACTION
Polyenes antibiotics Cell membrane inhibitors
Echinocandins Cell wall synthesis inhibitors
AT
Azoles Ergosterol synthesis inhibitors by inhibiting the 14a-demethylase

Hetrocyclic Interfere with mitosis
Benzofuran
T
Allylamines Lanosterol synthesis inhibitors by inhibiting squalene epoxidase

PA
Antimetabolites Nucleic acid synthesis inhibitors

G
F
PD
E
PL
M
SA

451
 Trifluridine is used as ophthalmic solution in Herpes keratitis.

 In pregnancy safest drug are –Zidovudine, Indinavir and Lamivudine.
ANTIMALARIAL DRUGS
S
 INTRODUCTION
P
 Malaria is a protozoal infection caused by Plasmodium parasite.
TI
 Malaria caused by four species of protozoal parasite - Plasmodium vivax, P. ovale,
ER
P. malariae, P. falciparum.
 50% malaria cases are due to Plasmodium falciparum.
G
N
FI
R
U
YO
AT
T
PA
G
F
PD
 LIFE CYCLE OF MALARIAL PARASITE

E
PL
Pre-erythrocytic
• Mosquito bites, sporozoites are injected with saliva into the
blood stream.
cycle
•
M
Primaquine for all species, Proguanil for P. falciparum

• The erythrocytic cycle inside human red blood cells (RBC)
SA
Erythrocytic • These are the drugs that kills schizonts in blood.

cycle • Fastest acting - Chloroquine, Mepacrine, Quinine, Mefloquine.
• Slower acting - Proguanil, Pyrimethamine, Sulfonamide
• The mosquito acquires gametocytes when it bites an infected
person.
Sporogonic cycle
• These fertilize in gut & eventually migrate as sporozoites to the
saliva.

SA
M
PL
E
PD
F
G
PA
T
PART
AT
YO
U
R
3
FI
N
G
ER
PHARMACOGNOSY
TI
P S
PHARMACOGNOSY
SP
TI
ER
 Pharmacognosy is defined as the scientific study of the structural, physical, chemical and
biological characters of crude drugs obtained from natural source (plant, animal and
G
mineral and marine). Derived from greek word
N
Pharmakon- Drug
FI
PHARMACOGNOSY
R
Gignosco- To acquire knowledge of
U
YO
HISTORY OF PHARMACOGNOSY
AT
T
PA
G
F
PD
E
PL
M
SA

471
Arista & Asava Arista Asava

The crude drugs are powdered The sugar or jaggery is
and its decoction (kashaya) is added to water, boiled
and cooled This is
prepared. The decoction is transferred to
filtered and transferred to fermentation vessel and
fermentation vessel. Sugar or drugs in the powder form
S
are added to it.
jaggery as required is added to the
eg- Punarnavasava
P
vessel and boiled
TI
eg- Ashokarishta
During soaking generating alcohol serves as preservative
ER
therefore have infinite period of self life
Avaleha Prepared by repeatedly boiling the decoction and extract
G
of drug and condensing with sugar or Jaggery. eg -
Drakshavaleha
N
Bhasma Powder of a substance obtained by calcination in which
FI
metal or minerals are converted into ash with herbal juice,
fruits etc.
R
HOMEOPATHY SYSTEM OF MEDICINE U
YO
AT
 Was developed by German Physician Hahnemann

 “Like can be Cured by like” (Similia similibus curantus)
T
7 Principles of homeopathy
PA
G
F
PD
E
PL
M
SA
CHINESE SYSTEM OF MEDICINE

Shennong – Father of Chinese Medicines
Based on 2 Hypothesis:
• Yin (Dark) and Yang (Light) theory
• Five elements theory
• Diseased conditions are the expressions of imbalance in yin and yang like excess
or deficiency of either of them

PLANT HORMONES/PLANT GROWTH REGULATORS
The organic compounds, other than nutrients which affect the morphological structure
or physiological processes
S
 PLANT HORMONES AND THEIR FUNCTIONS
P
TI
ER
G
N
FI
R
U
YO
AT
T
PA
G
F
PD
E
PL
M
SA

PHARMACOGNOSY
 CHEMICAL TEST FOR GLYCOSIDES

ANTRAQUINONE GLYCOSIDES
Boiled with Add chloroform
Drug Get filtrate after flitration
dil. H2 SO4 or ether
Borntrager’s test: Ammonical Organic layer is
(break –C- O-bond) separated
S
Layer become
pink due to Add
P
anthraquinone NH 3
TI
Modified
ER
Borntrager’s test : In this acid + FeCl3 use to break the –C-C- bond
(break –C- C-bond)
FLUORESCENCE CHEMICAL TEST AND OTHER
G
RHUBARB
(in U.V light) ACTIVITY FEATURES
N
Rhapontic Blue Contain rhaponticin having Sweet odour
FI
(Chinese) strong estrogenic activity
Not contain Rhaponticin,
Indian Deep violet the characteristic odour of Orange brown
R
the essential oil is due to the cork cells
U
presence of eugenol
YO
Other test for Shows red colour with addition of alkali, Give positive result for
rhubarb Modified Borntrager’s test
AT
ALOES VARIETY OF ALOES

CURACAO CAPE SOCOTRINE ZANZIBAR
Modified Aq. Solution of drug + FeCl3 + HCl on hydrolysis gives
T
Borntrager's test free anthraquinone which is Collected add organic solvent

PA
indicate presence of C- organic layer separated and shaken with ammonia .

glycoside which is aloe Ammoniacle layer shows rose pink to cherry colour
emodin
G
Nitrous acid test

Sharp pink to
F
(This test is due to Faint pink Very less change in colour

carmine color
isobarbaloin)
PD
Deep brown Brown colour Pale brownish Yellowish

Nitric acid test
red colour to Green - yellow colour brownish
E
Cupraloin test
Wine red
(Klung's Isobarbaloin Faint colour to
PL
persisting for No colour

test) CuSO4 + NaCl + Yellow
4 hrs
90% alcohol
M
CARDIAC GLYCOSIDES
SA
DIGITALIS DESCRIPTION
Keller kiliani test 1 gm Drug + 10 ml 70% Alcohol Extract + Lead
(to detect the acetate
Glacial
presence of acetic acid Transferred to a tube
digitoxose sugar) FeCl3 Reddish Green Color
containing 2 ml conc. H2 SO4

505
S
4
P
TI
PART
ER
G
N
FI
R
PHARMACEUTICAL
YO
U
CHEMISTRY
AT
T
PA
G
F
PD
E
PL
M
SA
Ä Physical Chemistry
Ä Inorganic Chemistry
Ä Organic Chemistry
Ä Medicinal Chemistry
Ä Pharmaceutical Analysis
PHARMACEUTICAL CHEMISTRY : PHYSICAL CHEMISTRY
SP
TI
ER
G
 POPULAR UNITS & THEIR SI EQUIVALENTS
N
PHYSICAL UNIT WITH
FI
EQUIVALENT IN SI UNIT
QUANTITY SYMBOL
Mass 1amu 1.6605x 10-27 kg
R
Energy 1eV 1.602 x 10-19 joule
Length
Volume
1Å
1 liter
U
10-10 m (10-1 nm)
10-3 m3 = dm3
YO
Force 1 dyne 10-5 N
1 atm 760 torr (760 mm Hg)
Pressure 1 bar 101325 pa or 105 pa
AT
1 torr 133.322 N m-2

T
 TERMS ASSOCIATED WITH ATOMIC STRUCTURE

PA
TERMS DESCRIPTION EXAMPLE

Isotopes Same atomic number but different 6 , 6C13, 6C14
C12
G
mass number
Isobars Same mass number but different 1H , 2He
3 3
F
atomic number
PD
Isodiaphers Same difference of number of 5B11, 6C13

Neutrons & Protons
Isotones Having same number of Neutron 1H , 2He
3 4
E
Isosters They are the molecules which have the CO2, N2O
PL
same number of atoms & electrons

Isoelectronic Species having same no. of Electron Cl–, Ar
M
 MOLE CONCEPT
SA
 A mole is defined as the amount of substance which contains same number of

elementary particles (atoms, molecules or ions) as the number of atoms present in
12g of carbon (C-12).
Amount of substance (in gram)
Number of moles =
Molar mass

547
PHARMACEUTICAL CHEMISTRY : PHYSICAL CHEMISTRY
 COMPARISON BETWEEN IDEAL & NON-IDEAL SOLUTIONS

NON-IDEAL SOLUTION
IDEAL SOLUTION SOLUTION HAVING POSITIVE SOLUTION HAVING
DEVIATION NEGATIVE DEVIATION
It obeys Raoult’s law Do not obey Raoult’s law Do not obey Raoult’s law
A-B = A-A or B-B A-B < < A-A or B-B A-B > > A-A or B-B
interactions interactions interactions
S
ΔHmix = 0 ΔHmix > 0 ΔHmix < 0
P
ΔVmix = 0 ΔVmix > 0 ΔVmix < 0
TI
Does not form an azeotrope Forms azeotrope mixture Forms azeotrope mixture
Example: Example: Acetone and Carbon Example:
ER
Benzene and Toluene, disulphide, Chloroform and Benzene,
Hexane and Heptane, Acetone and Benzene, Chloroform and Diether,
Acetone and Aniline,
G
All the Dilute solutions nearly Carbon Tetrachloride and
behave as an ideal solution Toluene, Nitric Acid and Water,
N
Acetone and Ethanol, Acetic Acid and Pyridine,
FI
Ethanol and Water Hydrochloric Acid and water
R
U
YO
AT
T
PA
 AZEOTROPES
G
 Azeotropes are binary mixtures having the same composition in liquid and vapour
phase and boil at a constant temperature.
F
PD
E
 DEFINITION
PL
 The properties that depend on the number of solute particles irrespective of their
M
nature relative to the total number of particles present in the solution are called
colligative properties.
SA
 There are four colligative properties:

S.NO NAME OF THE COLLIGATIVE PROPERTY
1. Relative Lowering of vapour Pressure
2. Elevation in Boiling Point
3. Depression in freezing point
4. Osmotic pressure

553
P S
TI
ER
 Limit test is defined as quantitative or semi quantitative test designed to identify and
control small quantities of impurity which are likely to be present in the substances.
G
 Identified by simple comparison of Opalescence, turbidity, or colour is compared with the
N
fixed standards as prescribed in the pharmacopoeias.
FI
 Usually the limits are prescribed in parts per million (PPM).
SUBSTANCE PRINCIPAL/ REACTION RESULT
R
Limit test of chloride based on  Reaction produces silver chloride
reaction between chloride ion and as white precipitate.U
YO
silver nitrate in the presence of  Opalescence produce in sample
CHLORIDE dilute nitric acid. solution should not be greater
Cl- AgNO3 dil. HNO3 AgCl NO -
than standard solution
AT
3
Chloride ion Silver nitrate White PPT
Silver chloride
Limit test of sulphate based on  Reaction produces barium

T
reaction between sulphate ion and sulphate.

PA
barium chloride in the presence of  Alcohol prevent super

dilute hydrochloric acid. saturation.
SULPHATE
 Turbidity of test solution is less
G
SO4- BaCl2 dil. HCl BaSO4 2Cl-

Sulphate Barium than that of standard solution the
ion chloride Barium Chloride
compound will pass the limit test
F
sulphate ion
of sulphate.
PD
Limit test of iron based on reaction  Reaction produces iron

between iron interect with thioglycolate complex as purple
thioglycollic acid in the presence of color
E
citric acid and ammonical alkaline  Citric acid form soluble complex
PL
IRON
solution. with iron and prevent
Fe4 -
2 HSCH2COOH
Citric acid CH 2SH OOC precipitation.
M
Fe2-
Ferrous
ion
Thioglycollic Ammonical
acid COO CH 2SH  Color develops only in presence
alkaline soln
SA
ferrous thioglycolate of alkali and color forms due to

(Purple colour complex) co-ordination compound.

PHARMACEUTICAL CHEMISTRY : INORGANIC CHEMISTRY
 APPLICATIONS OF RADIOPHARMACEUTICALS
RADIO NUCLIDE APPLICATIONS

Ammonium Bromide Injection (Br-82) Extracellular water measurement.
Calcium chloride Solution (Ca-45/Ca-47) Study of calcium metabolic disorders, bone
cancer and other bone lesions.
S
Chlormerodrin Injection (Hg-197/Hg- Scintillation scans of kidney.
203)
P
Chromatid serum album injection (Cr- Plasma volume determination and placental
TI
51) localization procedures
ER
Chromic chloride injection Study of protein loss from GIT and
Absorption.
Colloidal gold Injection (Au-198) Scintillation scan of liver, study of RES,
G
treatment of the carcinomas of pleural and
N
peritoneal cavities.
FI
Cyanocobalamin Capsules and Injection Co-57/58 → Diagnosis of pernicious anemia.
(Co-57, Co-58, Co-60) Co-60 → Treatment of advanced stages of
cancer involving cervix, vagina, uterus,
R
bladder and mouth, tongue etc.
Ferric chloride/citrate (Solution and Study of iron metabolism and RBC formation.U
YO
injections) Fe-59)
Indium chloride in chelate form Injection Brain and renal scans & plasma volume
(In-113) measurement.
AT
Iodinated Serum Albumin Injection (I- Determination of plasma volume, total blood
125) volume, circulation time and cardiac output,
Iodinated Serum Albumin Injection (I- localization of neoplasm of the brain.
T
133)
PA
Potassium chloride Injection (K-42) Study of (K+) ion exchange

Rubidium chloride Injection (Rb-86) Myocardial blood flow determination
G
Selenomethionine (Se-75) Pancreas and Parathyroid gland scans.

Sodium chloride injection (Na-24) Study of Na+ exchange.
F
Sodium fluoride (F-18) Bone scanning and study of bone metabolism

PD
Sodium iodide solution (I-125) Thyroid scanning and study of thyroid uptake
Sodium Iodide capsules and solution (I-
131)
E
Sodium iodohippurate Injection (I-131) Renal scanning and study of renal function.
PL
Sodium phosphate Solution (P-32) Treatment of polycythemia vera (over

production of RBC)
Sodium Rose Bengal Injection (I-131) Liver scan, liver function test.
M
Sodium sulphate solution (S-35) Extracellular flood volume determination

SA
Sodium Pertechnetate Injection (Tc-99) Brain scanning, Thyroid function tests

Technetium Sulphide Colloidal solution Liver and spleen scans
(Tc-99)
Yb-169 DTPA Brain scanning and determination of GFR in
(Diethylenetriaminopentacetate) kidneys.

577
P S
TI
ER
 INTRODUCTION
 Organic chemistry is the major branch of chemistry which deals with the scientific
G
study of preparation, structure, properties, composition and reactions of carbon
N
containing compounds.
FI
 In organic chemistry, not only hydrocarbons are studied but also compounds in which
R
carbon is bonded with any other atoms like oxygen, halogens, nitrogen, phosphorus
and sulfur etc. U
YO
 Almost all organic compounds contain atleast one carbon hydrogen bond (C-H) in
it.
 VFT (Vital Force Theory): By Berzelius in 1815.
AT
 Upto 1815, any organic compound could not be synthesized in lab. So Berzelius
suggested that there is a mysterious force in living organisms which was named as
T
Vital Force and said that organic compounds cannot be synthesized in lab. This
PA
theory was called as VFT.

 But in 1828 a German scientist Wohler synthesized an organic compound in lab.
G
Which was ‘urea’. So VFT was failed. Urea was synthesized in lab by heating of
F
Ammonium cyanate (NH4CNO).

PD
O
NH4CNO H2N C NH2
Ammonium Rearrangement
E
Urea
cyanate
PL
 CHARACTERISTICS OF CARBON ATOMS

M
 Atomic number of Carbon - 6

SA
 Electronic configuration - 2,4

 Valence of electrons - 4
 Tendency to form multiple bonds
Carbon atom can form

four single covalent bonds
eg- CH4 (Methane)

PHARMACEUTICAL CHEMISTRY : ORGANIC CHEMISTRY
 OPTICAL ACTIVITY
 The light whose vibrations occur only in one plane is termed plane polarised or
simply polarised. The device that brings polarisation in light is called a polariser.
 Polarimeter: An instrument used to measure optical activity
P S
TI
ER
G
N
FI
 OPTICAL ISOMERISM
 Compounds having similar physical and chemical properties but differing only in
R
the behaviour towards polarised light are called optical isomers and this
phenomenon as optical isomerism. U
YO
 Condition for compound to show optical isomerism
 The compound must have at least one asymmetric or chiral C-atom.
AT
 The compound must not have plane of symmetry.
Chiral molecules • A carbon atom attached with four COOH COOH

T
C * NH2
different groups or atoms.
H C * OH H
PA
• Rotate plane polarised light.

• Does not contain plan of CH3 CH3
Lactic acid Alanine
G
symmetry and inversion center.

Meso compounds • A meso compound is an achiral
COOH
F
molecule which has two or more

*
PD
chiral centers. HO H
meso-Tartaric acid
• It is optically inactive and it HO H
does not rotate the plane *
COOH
E
polarized light.
• It has plane of symmetry.
PL
Enantiomers • The non-superimposable Cl Cl

mirror images of a chiral H C
M
C H
C2H5 C 2 H5
compound are known as CH3 H3C
SA
enantiomers. Enantiomers of 2-Chloro butane

(1) Erythro • The set or pair of enantiomers
CH3 CH3
enantiomers with similar groups on the
same side of the carbon chain. H C OH OH C H
H C Cl Cl C H
Erythro
CH3 enantiomers CH3

589
Conformation of Butane [CH3-CH2-CH2-CH3]
CH3 CH3 CH3 CH3

H H
CH3 H
H CH3
60o 60o 60o
H H
H H H H H
HH H
S
CH3 H
H CH3
P
(I) (II) (III) (IV)
Fully eclipsed Gauche
TI
Eclipsed Fully Staggered
(less stable) (more stable) (most stable) (Anti form)
ER
Stability - Fully Staggered > Gauche > Eclipsed > Fully eclipsed
G
Conformation of Cyclohexane
 Most common naturally available cyclic compounds contain six member rings
N
because such rings exist in almost completely strain free conformation. This is
FI
called as chair conformation.
R
Chair Half chair
U
Twist Boat Boat
YO
(Most stable) (Less stable)
Stability - Chair > Twist Boat > Boat > Half chair
AT
T
PA
 INTRODUCTION
G
Chemical reactions occur by the formation of bond between the atoms or breaking of
bond between the atoms and leads to formation of stable products.
F
PD
 TYPES OF BONDS
Ionic bond or This bond is formed due to the electrostatic attraction between no
Electrovalent bond two oppositely charged stable ions.
E
eg - NaCl, KCl & AlF3.

PL
Covalent bond Formed by mutual sharing of electrons between two atoms.

eg - Single, Double & Triple bonds
M
Co-ordinate covalent A bond formed by donating a pair of electrons to another atom.

bond or Dative bond eg - Ozone (O3) [O=O→O]
SA
 SIGMA () AND Pi () BOND
SIGMA BOND () PI BOND ()

This is formed due to overlapping of pure s-s, This bond is formed due to lateral or
s-p, p-p or hybrid orbitals of two atoms along sidewise or parallel overlapping of pure ‘p’
their inter-nuclear axis. orbitals of two atoms.

593
 CHEMICAL REACTION OF ALKENES

H2
Alkanes H2O/H +
R CH CH3
X MK rule
X2/CCl4 rearrangement OH
R CH CH2
X Alkenes BH3/H2O2
H X R CH2 CH2OH
R CH CH3 R CH CH2 OH - AMK rule
S
MK rule [No rearrangement]
X rearrangement
P
OH
X
(i) (AcO)2Hg/H 2O
TI
X2/H 2O R CH CH3
R CH CH2
No rearrangement (ii) NaBH4/HO- [No rearrangement]
ER
OH MK rule
G
N
FI
 Alkynes have a general formula of [CnH2n –2].
 These are the acyclic hydrocarbons which contain carbon-carbon
R
C C
triple bond is called alkynes
 The hybridization of carbon atoms having triple bond (CC) in alkynes is sp. U
YO
 METHOD OF PREPARATION OF ALKYNES
AT
Br Br
(i) Alc. KOH
CH2 CH2 H2O
(ii) NaNH 2
CaC2
T
Br
PA
(i) Alc. KOH Electric arc/12000C

H3C CH 2C + H2
(ii) NaNH 2 Berthelot's process
G
Br
Br Br CH COOK
Kolbe's electrolysis
F
Zn dust/MeOH
Br CH CH Br CH COOK
PD
1500C
HC Br (i) NaNH 2/or Na
Zn/MeOH H C C R
(ii) R.X.
CH Br 1500 C
E

CH3MgI
PL
Alc. KOH
H2C CH Cl H C C H (CnH 2n-2) H C C R
or NaNH2 (ii) RX
or
M
CHCl3 + 6Ag + I3CH R C C H Isomerization

or
SA
Alc. KOH
R C C R
NaNH 2
liq. Paraffin

607
 METHOD OF PREPARATION OF ANILINE

NO2 O
Sn/HCl,Fe/HCl,TiCl2/ Curtius
HCl,SnCl2/HCl NaN3/ Cl C
(Reduction) Reaction
LiAlH4 /H2O2,H 2/Ni H 3O+ O
Sn/HCl, Fe/HCl,TiCl2 H 2N-NH2/
NH OH Cl C
/HCl, SnCl2/HCl HONO/H+
S
O
Sn/HCl2, Fe/HCl, TiCl2 H2N-OH/AcOH Lossen
P
NH NH Cl C
NH 2 H 3O+ Reaction
/HCl,SnCl2/HCl,HSO4
TI
Sn/HCl2, Fe/HCl, TiCl2 Zn/HCl
-Cl+N
N N 2
ER
/HCl,SnCl2/HCl,HSO4
Cl ANILINE Cl-NH2   
NH3/Cu 2O,200°C-300°C BrMg
OH
G
NH3/ZnCl2 /300°C
N3H/
NaNH2/liq. NH3
N
O C NH2 Br2KOH H 2SO4 Br
FI
COOH
Hof fmann Bromamide Degradation
Schmidt Reaction
R
 CHEMICAL REACTION OF ANILINE
U
YO
NH 2
AT
Br H2N + Br Br2/CCl4
O C
Cl O
Cl NH C NH
NH 2 Diphenyl Urea
T
PA
Br Br
Na + NHNa
Br2/H2O
G
Br
NH 2 NH2 CHCl3 N C
NH 2
F
KOH
HNO3 + H2SO4 Carbylamine Test
+
PD
Cl-Ph
NO2 NH
ANILINE CuCl2/200°C
NO 2
O
E
NH2 NH2
NaNO2/HCl
H 3C C Cl
PL
N2+Cl-+ 2H2O
+ NO2 HNO3+H2SO4
/H3O+
0-5°C
NaCr2O7
M
Aniline Black
Conc. H2SO4
NO2
SA
H 2SO4 K2Cr2 O7/H+

H2N SO 2OH O O
180°C

P S
TI
ER
 Autonomic nervous system (ANS) is
involuntary in nature and the activity of this
G
is maintained automatically
N
FI
 The ANS has two divisions – Parasympathetic
and Sympathetic. Sympathetic system is more
R
widely than Parasympathetic activity.
U
YO
Autonomic nervous system
AT
Parasympathetic system Sympathetic system
Parasympathomimetic Sympathomimetic
T
(Cholinergic drugs) (Adrenergic drugs)

PA
Parasympatholytic Sympatholytic
(Anticholinergic drugs) (Antiadrenergic drugs)
G
F
 CHOLINERGIC DRUGS (PARASYMPATHOMIMETIC)

PD
 Acetylcholine receptor stimulants and cholinesterase inhibitors together comprise a

large group of drugs, called as cholinergic drugs that mimic the actions of acetylcholine.
E
 Cholinoceptor stimulants are classified pharmacologically by the spectrum of action

PL
depending on the type of receptor muscarinic or nicotinic.

M
 Basic moiety of Cholinergic drugs

SA
DRUG NAME BASIC MOIETY

Acetylcholine Onium group
Muscarine Tetrahydrofuran
Pilocarpine Tetrahydrofuran and imidazole
Physostigmine Indole and pyrrolidine

PHARMACEUTICAL CHEMISTRY : MEDICINAL CHEMISTRY
 Basic moiety of Sedatives & Hypnotics Drugs

DRUG NAME BASIC MOIETY
Phenobarbitone, Pentobarbitone, Barbituric acid
Amobarbital, Barbital and
Mephobarbitone,
Diazepam, Nitrazepam, Oxazepam & 1,4-benzodiazepine-2-one
S
Prazepam
P
Chlordiazepoxide 1,4-benzodiazepine-4-oxide
TI
 Structures and IUPAC Name of Drugs
ER
BENZODIAZEPINES
Diazepam Nitrazepam Oxazepam
G
CH3
O
N
O 9 NH 1 1
O
9
N1 8 2 9 NH
FI
8 2 2
8
3
3 O2N OH
Cl 7 N4 Cl 3
N4 6 7 N
R
7 5
6 5 1,4-benzodiazepine 6 5 4
1,4-benzodiazepine -2-one 1 1,4-benzodiazepine
-2-one 6
U 2 -2-one
YO
5 3
4
7-Choloro- 1-methyl-5-phenyl 7-Nitro-5-phenyl-1H-1,4- 7-Chloro-3-hydroxy-5-phenyl -1,4

3H- 1,4-benzo diazepin2-one benzo diazepin-2-one benzodiazepine-2-one
AT
Chlordiazepoxide Prazepam
NHCH3 CH2
T
1
9
N 1
PA
8 2 9 N O
8 2
3
Cl 3
7 N O Cl
G
6 5 4 7 N4
6 5
1,4-benzodiazepine
4-oxide 1,4-benzodiazepine
F
-2-one
PD
7-Chloro-2-methylamino-5-phenyl-3H-1,4- 7-chloro-1-(cyclopropyl methyl)-5- phenyl- 2H-

benzodiazepine-4-oxide 1, 4-benzodiazepine -2-one
E
BARBITURATES
PL
Phenobarbitone Pentobarbitone Amobarbital

O O
M
O
C2H5 C2H5
CH3 C2H5
NH
SA
6 6
5 1
NH C3H7 HC 5 1
5
6
NH
C6H5 Barbituric acid 4 2 H3C CH CH2 CH2 1
4
3 2 CH3 3
4 3 2 1 4 2
O NH O 3
O NH O O NH O
5-Ethyl-5-phenyl barbituric 5-Ethyl-5-(1-methylbutyl) 5-Ethyl-5-(3-methylbutyl)

acid barbituric acid barbituric acid

Gpat Discussion Center Pvt. Ltd. |  www.gdclive.com, www.gdconlinetest.in |  gdcgpat037@gmail.com |
8602227444, 9770765680
657
PHARMACEUTICAL CHEMISTRY : MEDICINAL CHEMISTRY
SYMPATHETIC INHIBITORS
α+β adrenergic blockers α-adrenergic blockers
Labetalol 3
Phenoxybenzamine
2
O 1 4 CH3
1 6 1
H2N C OH CH3
6 5 O CH2 CH N CH2
HO 2 5
CH CH2 NH CH CH2 CH2 Phenoxy
1 2 2 3 4 C2H4Cl Benzyl amine
S
3 4
P
2 hydroxy-5-(1-hydroxy-2-[(4-phenyl-2-butanyl) N-Benzyl-N-(2-chloroethyl)-1-phenoxypropan- 2-
amino] ethylbenzamide amine
TI
Central sympatholytics CALCIUM CHANNEL BLOCKERS
Clonidine Verapamil
ER
Cl OCH3
H3CO 3 3
2 CH(CH3)2 CH3 2
2 NH
1 2
3 1
G
3 4 5
NH 5 H3CO
4 1
C (CH2)3 N(CH2)2
1 4
OCH3
2 2
6 5
N
6 1 CN 6 5
4 Cl N3 4
5 Imidazole 2-(3,4-Dimethoxyphenyl)-5-{[2-(3,4-dimethoxy
FI
phenyl)ethyl]-(methyl)amino}-2-prop-2-yl
N-(2,6-Dichlorophenyl)-imidazol-2-amine pentane nitrile
Nifedipine Isradipine Diltiazem
R
OCH3
6
COOCH3
2 1 O
2 3
N U 1, 5-Benzothiazepine
YO
5 3 COOCH3
CH3 N 9 1S 2
1 4 1
1,4-Dihydro 3 2
4 NH Pyridine CH3 8 3
1
7
4 4
NH 1,4-Dihydro OCOCH3
6 CH3
3 2 5 Pyridine 7 4
6 5 5 6 CH3 5N
NO2 COOCH3 6
AT
2,1,3-Benzoxadiazole CH3 O
C O CH
O CH3 (CH2)2N(CH3)2
1-2
3,5-dimethyl 2,6-dimethyl-4-(2- 3-methyl 5-propan-2-yl 4-(2,1,3- 5-[2-(dimethylamino)ethyl]-2-(4-
nitrophenyl)-1,4-dihydro benzoxadiazol-4-yl)- 2,6-dimethyl- methoxyphenyl)-4-oxo-2,3-
T
pyridine-3,5-dicarboxylate 1,4-dihydropyridine-3,5 dihydro -1,5-benzothiazepine-3-

PA
dicarboxylate acetate
ARTERIOLAR DILATOR Deserpidine
Minoxidil
G
NH2 -Carboline
F
2 3 N
2
N1 NH
PD
3 1
6 4 Indolo[2',3':3,4]pyrido
O N N [1,2-b]isoquinoline
O OCH3
4 5 6 5 H3COOC O C OCH3
E
NH2 OCH3
OCH3
PL
2,4-diamino-6-piperidino pyrimidine-3- Methyl-2-methoxy-3-[(3,4,5-

oxide trimethoxybenzoyl) oxy] indolo [2',3':3,4]
M
pyrido[1,2-b]isoquinoline-1-carboxylate
SA
 Note point-
 (R, R) isomer of labetalol is Clinically used.
 Enalapril is ACE inhibitor, used in treating cardiovascular disorder &
synthesized from the natural amino acids L-alanine and L-proline.
 Nifedipine when exposed to day light and artificial light, is readily converted to
a derivative nitrosophenylpyridine.

Gpat Discussion Center Pvt. Ltd. |  www.gdclive.com, www.gdconlinetest.in |  gdcgpat037@gmail.com |
8602227444, 9770765680
665
PHARMACEUTICALCHEMISTRY: PHARMACEUTICALANALYSIS
SP
TI
ER
The pharmaceutical analysis is a branch of chemistry, which deals with the process or sequences
of processes to identify and/or quantify a substance or drug, the component of pharmaceutical
G
substance or determination of the structure of chemical compound used in the formulation of
N
pharmaceutical product.
FI
 DIFFERENT TECHNIQUES OF ANALYSIS
Analysis is broadly divided into two types:
R
QUALITATIVE ANALYSIS QUANTITATIVE ANALYSIS
It gives information about the identity of U
YO
It establishes the relative amount of one or
atomic and molecular species or the
more of the species (analyte) in numerical
functional groups in samples. It is used
terms. It measures the concentration or
only to determine the presence and
AT
amount of each substance in a sample.

absence of the compound.
 CLASSIFICATION OF ANALYTICAL METHODS
T
PA
Volumetric Analysis
MMETHODS OF ANALYSIS
Chromatographic Techniques
- Acid-Base Titration Planner
G
Aqueous - Paper Chromatography, TLC, HPTLC

Non Aqueous Column
- Redox Titration - Gas Chromatography, Column Chromatography
F
- Precipitation Titration - Size Exclusion Chromatography, HPLC, Flash chromatography

- Complexometric - Ion Exchange chromatography, Affinity Chromatography
PD
Spectral Analysis
Instrumental - Colorimetry, UV-Visible Spectroscopy, Infrared Spectroscopy
- NMR Spectroscopy, Mass Spectroscopy, Electron Microscopy
- Atomic Absorption, Flame Photometry, X-ray Spectroscopy
E
Electro Analytical
PL
- Potentiometry, Conductometry, Voltammetry

Non Instrumental - Amperometry, Polarography, Coulometry, Electrogravimetry
Biological Methods Hyphenated Techniques

- GC-MS, LC-MS, LC-NMR, EC-MS, CE-MS, LC-MS-MS, GC-NMR
- In-vitro Methods
- Animal Study Miscellaneous Techniques
SA
- Microbiological Assay - Kjeldahl Methods, RIA, ELISA, Diazotization, Karl Fischer

- TGA, DSC
Chemical Methods
 SOME IMPORTANT DEFINITIONS
Volumetric or It consists of determination of volume of solution of accurately
Titrimetric known concentration required to react completely with the solution
Analysis of substance to be determined.

 ACCURACY AND PRECISION Low accuracy Low accuracy

Low precision
 Accuracy- Accuracy is ‘the degree of High precision
agreement between the measured value

and the true value’. An absolute true value
is seldom known. So, the term accuracy
refers to how near the observed value High accuracy High accuracy
S
Low precision High precision
is to true or standard value. Or
P
“Closeness of a measured value to the
TI
true or accepted value”.
ER
 Precision- Precision is defined as the degree of agreement between replicate
G
measurements of the same quantity. It is the repeatability of a result. The precision may
be expressed as the standard value. So, the term precision refers to nearness between several
N
measurements of the same quantity.
FI
R
 TITRATION U
YO
 A titration is a technique where a solution of known concentration is used to determine
the concentration of an unknown solution.
AT
TYPES OF TITRATION
T
PA
Acid base Redox Precipitation Non aqueous Complexometric

titration titration titration titration titration
G
F
ACID BASE TITRATION

PD
 ACID BASE TITRATION - An Acid-Base titration involves strong or weak acids or bases.
E
Specifically, an acid-base titration can be used to figure out the following:

PL
1. The concentration of an acid or base.

2. Whether an unknown acid or base is strong or weak.
M
3. pKa of an unknown acid or pKb of the unknown base.

SA
ACID BASE
 An Acid is a substance that can release  A Base is a substance that can release
ion (H+) when dissolved in water. a hydroxyl ion (OH-) when dissolve in
 Acid converts blue litmus paper to red water.
having the pH < 7.  Base converts red litmus paper to blue
Example: HCl  H+ + Cl- having the pH >7.
Example: NaOH  Na+ + OH-

Strength of Same as that of titrate 5 or 10 times stronger than titrate

titrant
Dependency Temperature dependent Temperature dependent
POLAROGRAPHY
P S
 POLAROGRAPHY is an electrochemical method of analysis based on the measurement of
TI
current flow resulting from the electrolysis of a solution at a polarisable microelectrode as a
ER
function of applied voltage.
PRINCIPLE in polarography is that a gradually increasing negative potential
G
(voltage) is applied between a polarisable and non-polarisable electrode and the
corresponding current is recorded. From the current voltage curve (Sigmoid shape),
N
qualitative and quantitative analysis can be performed.
FI
 HALF WAVE POTENTIAL The Half wave potential is the potential at the point of inflection
R
in the current-voltage curve. E1/2 is characteristic or specific for every electroreducible ion
U
or functional group. At this potential, 50% of the reduced form and 50% of the oxidised
YO
form are present.
AT
T
PA
G
F
PD
E
 DIFFERENT TYPES OF CURRENTS USED IN POLAROGRAPHY

PL
Residual Current It is a non-faradic current. This current increases linearly with the
(ir) applied voltage, and it is observed even when the purest, air free
M
solutions are used.

SA
It is the sum of the relatively larger condenser current (ic) and a

very small faradic current (if ).
ir = i f + i c
Diffusion current Resulting from reduction or oxidation of sample: It is calculated
(id) by following equation known as Ilkovic equation
Id = 607. 𝑛 CD1/2 𝑚2/3 𝑡1/6

 WOODWARD-FIESER RULE
 Homoannular Diene: It is a cyclic diene having conjugated double bond in the same
ring.
CH3
P S
H3C
TI
 Heteroannular diene: It is a cyclic diene in which double bonds in conjugation are present
in different rings.
ER
G
N
 Endocyclic double bond: A double bond present in a ring as shown in the example.
FI
Exocyclic double bond: A double bond in which one of the double bond is a part of a
ring system shown in ring B
R
exocyclic double bond
U
YO
AT
Endocyclic double bond

T
Ring A has one endocyclic and one

PA
exocyclic double bond

A B Ring B has only one endocyclic double
bond
G
(A) For dienes, trienes and polyenes

F
FOR DIENES, TRIENES AND POLYENES

PD
Homoannular conjugated diene

253 nm
E
PL
Heteroannular conjugated diene

Parent value 215 nm
M
SA
Butadiene or a cyclic conjugated

dienne CH2 217 nm
H2C
Acyclic triene 245 nm
Each alkyl substituent or Ring residue + 5 nm
Increments Exocyclic double bond + 5 nm
Double bond extending conjugation + 30 nm

S
5
P
TI
PART
ER
G
N
FI
R
OTHER SUBJECTSU
YO
AT
T
PA
G
F
PD
E
PL
M
SA
Ä Biochemistry
Ä Biotechnology
Ä Microbiology
Ä Pharmaceutical Management
OTHER SUBJECTS : BIOCHEMISTRY
S
 Biochemistry can be simply defined as, “chemistry of the living cell”.
P
TI
 The term Biochemistry was introduced by Carl Neuberg in 1903.
ER
Carl Neuberg
G
N
 Carbohydrates are organic compounds with general formula Cn(H2O)n .
FI
 Carbohydrates may be defined chemically as aldehyde or ketone derivatives of polyhydroxy
R
(more than one hydroxy group) alcohols or as compounds that yield these derivatives on
hydrolysis. U
YO
 The term ‘sugar’ is applied to carbohydrates soluble in water and sweet to taste.
 They are the most abundant dietary source of energy (4 Cal/g) for all organisms.
AT
1 CHO 1 CHO
1 CH2OH
H C OH C O H 2C OH
2
T
2
HO C H HO C H HO 3 C H
PA
3 3
H C OH H C OH HO 4 C H
4 4
G
H C OH H C OH H 5C OH
5 5
6 CH2OH 6 CH OH
F
6 CH2OH 2
Glucose (C6H12O6) Fructose(C6H12O6) Galactose (C6H12O6)
PD
(Aldose) (Ketose) (Aldose)
 CLASSIFICATION OF CARBOHYDRATES
E
PL
CLASSIFICATION TYPES EXAMPLES

MONOSACCHARIDES Triose (C3H6O3) Glyceraldehyde,
M
Dihydroxyacetone
SA
Tetrose (C4H8O4) Erythrose, Erythrulose

Pentose (C5H10O5) Ribose, Ribulose, Deoxyribose,
Xylose, Xylulose
Hexose (C6H12O6) Glucose, Galactose, Mannose,
Fructose
Heptose (C7H14O7) D-Sedoheptulose

759
OLIGOSACCHARIDES Disaccharides Sucrose, Lactose, Maltose

Trisaccharides Raffinose, Gentianose
POLYSACCHARIDES Homopolysaccharide Starch, Dextrin, Inulin, Glycogen,
Cellulose
Heteropolysaccharides Hyaluronic acid, Chondroitin,
Heparin, Keratan sulphate,
S
Dermatan sulphate.
P
TI
ISOMERISM SHOWN IN MONOSACCHARIDES
Epimers Two monosaccharides differ from each other in their configuration
ER
around a single specific carbon glucose and galactose carbon 4
(C4-epimers). They differ in the arrangement of OH group at C 4.
G
Anomers The α and β cyclic forms of D-glucose
N
Mutarotation Change in the speci ic optical rotation → α and β forms of D-glucose
FI
to an equilibrium mixture.
Enantiomer Mirror image of each other (D-Glucose & L-Glucose)
R
Diastereomers Not mirror image of each other (D-Glucose [C2, C4], D-Mannose [C2]
& D-Galactose [C4])
U
YO
DISACCHARIDES
Reducing disaccharides Free aldehyde or keto group e.g. Maltose, Lactose.
Non-reducing disaccharides No free aldehyde or keto group e.g. Sucrose, Trehalose.
AT
SUCROSE LACTOSE MALTOSE

6 CH OH 1CH2OH 6 CH2OH 6 CH2OH 6 CH2OH 6 CH2OH
T
2
5 O O 5
O 5 O 5 O 5 O
PA
HO CH2 H OH
2 5
HO 4 1 O 4 1 1 1
4 1 4 O
OH CH2OH OH OH OH 4 OH
HO O 4 6 2 H CH2 HO OH
G
2 3 2 2
3 3 3 2 3
OH 3
OH OH OH OH OH
- D-Glucose -D-Fructose -D-Galactose -D-Glucose -D-Glucose -D-Glucose
F
PD
 COMPOSITION AND GLYCOSIDIC LINKAGE OF CARBOHYDRATES
CARBOHYDRATES SUGAR UNIT LINKAGE

E
Sucrose α- D Glucose + β-D Fructose α, β (12)

PL
(Cane sugar & Invert

sugar)
M
Lactose β-D- Glucose + β-D- Galactose β (14)

SA
(Milk Sugar)
Maltose α-D- Glucose + α-D- Glucose α (14)
Cellulose Unbranched polymer of β-D- β (14)
Glucose
Starch Polymer of Glucose Amylose - α - 14
(Glucosan or Glucan) Amylopectin - α- 16
Inulin Polymer of Fructose -

760 Gpat Discussion Center Pvt. Ltd. |  www.gdclive.com, www.gdconlinetest.in |  gdcgpat037@gmail.com | 8602227444,
9770765680
Quaternary • Only those protein having more than one polypeptide chain
Structure (polymeric) have quaternary structure.
• Bonds responsible for protein structure Covalent bonds -
Peptide bond & Disulfide bonds, Non-covalent bonds -
Hydrogen bonds, Hydrophobic bonds, Electrostatic bonds &
Van der Waals forces.
S
• E.g.- Hemoglobin, Creatine kinase, Lactate dehydrogenase
P
TI
 METABOLISM OF AMINO ACID
ER
NAME OF PATHWAY CYCLE
Urea Cycle/ Krebs
G
Henseleit cycle
N
 Urea is the end
product of protein
FI
metabolism
 Rate Limiting Step /
R
Enzyme - Carbamoyl
phosphate synthetase U
YO
 Location – Liver
 The urea cycle is
irreversible and
AT
consumes 4 ATP.
T
PA
 TEST FOR PROTEINS

G
TEST REAGENT OBSERVATION AMINO ACID

Biuret Test KOH + hydrated Purple color Confirms the presence
F
copper sulphate + (Copper coordinate of peptide bond /

PD
sodium potassium complex) linkage (Protein)

tartrate
Folin- Sodium tungstate For colorimetry assay Phenolic group
E
ciocalteu and sodium (Tyrosine)

PL
Test molybdate
Heller’s Test HNO3 White precipitate Coagulation test for
M
albumin in biological
SA
fluid including urine.

Hopkins- Glyoxylic acid Violet or Purple Indole ring
Cole reaction color (Tryptophan)
Millon’s Test Mixture of sulphuric Red Phenolic (Tyrosine)
acid and mercury Presence of soluble
sulphate + Sodium protein
nitrite

Essential fatty acid: - Fatty acid that cannot be synthesized by human body, commonly
they are polyunsaturated fatty acid (PUFA).
 Arachidonic acid
 Linoleic acid
 Linolenic acid
 Lipoproteins consist of a lipid core containing nonpolar triacylglycerol and cholesterol
S
ester surrounded by a single layer of amphipathic phospholipids and free cholesterol
P
molecules with some proteins (apoprotein).
TI
ER
G
N
FI
R
U
YO
AT
 CLASSIFICATION OF LIPOPROTEINS
DIAMETER TRIACYLGLY PROTEIN

T
LIPOPROTEINS DIAGRAM FUNCTION

(nm) CEROL (%) (%)
PA
HDL
• Formed in the liver
• Deliver cholesterol
G
(High density 10-20 12 40

from peripheral
lipoprotein)
F
tissue to liver
•
PD
Derived from VLDL

remnant
LDL
(Low density 20-25 12 20
• They transport
E
cholesterol from
lipoprotein)
liver to other
PL
tissues.
VLDL • Formed in the liver
M
(Very low-
30-90 55 10
• Carry endogenous
SA
density triacylglycerol
lipoprotein)
• Formed in the
intestine
Chylomicron 100-1000 88 2 • Carry dietary
triacylglycerol to
various tissues

771
7. Lipid storage diseases

a. Niemann Pick disease Sphingomyelinase
b. Farbers disease Ceramidase
c. Gaucher's disease β-Glucosidase (glucocerebrosidase)
d. Krabbe's disease β-Galactosidase (Galactosylceramidase)
e. Tay-sachs disease Hexosaminidase A
S
f. Fabry's disease α-galactosidase
8. Disorders of Nucleic Acid Metabolism
P
a. Hyperuricaemia Elevation in serum uric acid
TI
b. Gout Overproduction of uric acid resulting in
ER
deposition of sodium urate crystals in the joints
causing inflammation
c. Pseudogout Deposition of calcium pyrophosphate crystals in
G
joints
N
d. Lesch-Nyhan syndrome (sex HGPRT (Hypoxanthine-guanine phosphoribosyl
FI
linked metabolic disorder, transferase)
affects only males)
R
U
YO
AT
 ELECTRON TRANSPORT CHAIN
 The energy-rich carbohydrates (particularly glucose), fatty acids and amino acids
T
undergo a series of metabolic reactions and, finally, get oxidized to CO2 and H2O.
PA
 The reducing equivalents from various metabolic intermediates are transferred to

coenzymes NAD+ and FAD to produce, respectively, NADH and FADH2.
G
 The mitochondria are the centres for metabolic oxidative reactions to generate
F
reduced coenzymes (NADH and FADH2) which, in turn, are utilized in ETC to liberate
PD
energy in the form of ATP.

 Structural organization of respiratory chain
 The inner mitochondrial membrane can be disrupted into five distinct respiratory
E
PL
or enzyme complexes, denoted as complex I, II, III, IV and V.

 The complexes I-IV are carriers of electrons while complex V is responsible for ATP
M
synthesis.
SA
 OXIDATIVE PHOSPHORYLATION
 The process of synthesizing ATP from ADP and Pi coupled with the electron transport
chain is known as oxidative phosphorylation.
 The mitochondrial oxidation of NADH with a classical P : O ratio of 3.

779
VITAMIN E VITAMIN K
R3 CH3 CH3
CH3 Vitamin K1
O1 CH3
(Phylloquinone) CH2 CH C CH2 (CH2 CH2 CH CH2)3 H
R2 7 8 9 2 CH 2 (CH2 CH2 CHCH2)3 H
6 10 CH3 O
HO 5 3 Vitamin K2
4 (Menaquinone) (CH2 CH C CH2)6 H R1
R1 VITAMIN E R1 R2 R3 Vitamin K3
Tocopherol -CH3 -CH3 -CH3 (Menadione) CH3
S
CH3
Tocopherol -CH3 -H -CH3 Naphthaquinone
O
P
Tocopherol -H -CH3 -CH3
TI
WATER SOLUBLE VITAMINS
VITAMIN B1 VITAMIN B9
ER
Reactive carbon N N
NH2
H2N O
S
G
N CH2 NH C NH CH COO-
N CH2 N+ O- O- N
CH2
N
H3C CH2 CH2 O P O P O- OH Para amino
Pteridine benzoic acid CH2
N
FI
CH3 O O COO-
Pyrimidine Pteroic acid Glutamate
Thiazole Pyrophosphate
Folic acid
R
Methylene
bridge
Thiamine
U
YO
Thiamine pyrophosphate (TPP)
VITAMIN B6 VITAMIN C
R1
AT
Vit B6 R1 OH
O
HO CH2OH Pyridoxine -CH2OH HO CH2 CH O
H3C
T
Pyridoxal -CHO HO OH
N
Pyridoxamine -CH2NH2
PA
G
 VITAMINS AND DEFICIENCY DISEASES (FAT SOLUBLE)

F
VITAMINS DEFICIENCY DISEASES

PD
Vitamin A Night blindness, Xerophthalmia, Keratomalacia

Vitamin D Rickets (In children), Osteomalacia (In adults)
E
Vitamin E Sterility in males and abortions in females, Weak immune system

PL
Vitamin K Bleeding diathesis

M
 VITAMINS, COENZYMES, DEFICIENCY DISEASES (WATER SOLUBLE)

SA
FUNCTIONS OF
VITAMINS COENZYMES DISEASES
COENZYMES
Thiamine TPP (Thiamine Oxidative • Beriberi
(Vit. B1) pyrophosphate) decarboxylation Wernicke -
Transketolase reactions Korsakoff
syndrome

P S
TI
ER
 Biotechnology is a branch of biology involving the use of living organisms and bioprocesses
in engineering, technology, medicine and other fields using
G
bio products.
N
 The father of biotechnology is Louis Pasteur.
FI
 Insulin was the first pharmaceutical product of
recombinant DNA technology approved for human use.
R
 HISTORICAL BACKGROUND OF BIOTECHNOLOGY U
YO
NAME AND YEAR DISCOVERIES
Karl Ereky 1917 Term biotechnology
AT
Robert hooke 1665 Cell

Robert brown 1833 Nucleus ( Plant cell )
Johann friedrich 1869 DNA
T
Watson and crick 1953 DNA structure

PA
Wilhelm ludvig Johannsen 1909 Gene

Thomas hunt morgan 1919 XY (male ) , XX ( female )
Marshall Nirenberg 1964 Genetic code
G
William j rutter 1987 Genetically engineered vaccine against hepatits B

F
Boyer and cohen 1973 Recombinant DNA technology

Kohler and Milstein 1975 Production of monoclonal antibodies
PD
Yuet wai kan 1976 Sickle cell anaemia

Albrecht kossel 1879 Nucleic acid
E
Edouard van beneden 1882 Specific no. of chromosomes

Oswald T. avery 1944 Genetic information
PL
M
SA
 The father of plant tissue culture is Gottlieb Haberlandt (1902).

 Plant tissue culture is a practice used to propagate plant under sterile condition often
to produce clone of plant.

PHARMACEUTICS : BIOTECHNOLOGY
Totipotency (Toti= Total, Potency = ability)

TWO UNIQUE Plant cell ability to develop into the whole plants
PROPERTIES OF
PLANT TISSUE Plasticity (Plant cell adaptability property)
In nutrient medium plant cell adaptation to grow
S
 EXPLANT
P
 An excised piece of differentiated tissue or organ is regarded as an explant.
TI
 General steps involved in tissue culture
ER
G
N
FI
R
U
YO
1 2 3 4
AT
T
PA
 TYPES OF TISSUE CULTURE

G
TYPES OF
F
DESCRIPTION DIAGRAM
CULTURE
PD
Callus  Callus culture is an unorganized mass of cell

culture formed when cell or tissue are cultured on solid
medium.
E
 Callus cells are parenchymatous in nature.

 Pair of hormones required for a callus to
PL
differentiate are Auxin and Cytokinin.

 A temperature in the range of 22-28C is suitable.
M
Suspension It suspension of individual or clumps of cell formed

SA
culture when cell or tissue culture in liquid.
Meristem Meristem culture is undifferentiated cultivation of

culture apical meristem called meristem culture

789
PHARMACEUTICS : BIOTECHNOLOGY
 PREPARATION OF PLANT TISSUE CULTURE MEDIA
Add the micronutrient and macronutrient solution in the desired amount of

distilled water and stir it well
Add the other components such as hormones, sucrose, and agar powder. Add
S
vitamins and auxins after autoclave to achieve better results
P
TI
Add more water to achieve the final volume of the medium
ER
Measure the pH of the medium and adjust it to pH 5.7
G
by adding 0.1N NaOH or 0.1N HCL
N
FI
In case of solid medium add agar in this medium and heat the
solution to dissolve the agar properly.
R
U
Dispersed the medium into different culture vessels and plug
YO
them by using non-absorbent cotton wool.
Autoclave them at 121 degrees centigrade under 15 psi

AT
The medium to cool down at room temperature

T
PA
 MAJOR TYPES OF MEDIA
White’s medium It is developed for root culture.

G
MS medium Murashige and Skoog originally formulated a medium to induce

organogenesis and regeneration of plants in cultured tissue.
F
B5 medium Developed by Gamborg.

PD
It is used for protoplast culture.

N6 medium Developed by Chu.
It is used for cereal anther culture.
E
Nitsch’s medium Developed by Nitsch.

PL
It is used for anther culture.

M
 TISSUE TRANSPLANTATION
SA
TERMS DEFINITION
Autograft Tissue transferred from one side to another side within the same
individual organism.
Isografts Tissue transferred from one site to another between genetically
identical individuals, e.g. uniovular twins.
Allografts Grafts between genetically different individuals of the same species.
Xenografts Grafts between different species.

791
 GENE TRANSFER TECHNIQUES

GENE TRANSFER
VECTOR MEDIATED VECTOR – FREE

(DIRECT GENE TRANSFER)
S
Agrobacterium Plant viral vectors
Physical methods Chemical methods
• Use of cDNA
P
(Ti plasmid) mediated
• Crown gall diseases • Electroporation • PEG mediated
• RNA plant virus • Microinjection
TI
(A. tumefaciens) • Fusion of protoplast
• Hairy root diseases • Silicon carbide whisker with liposomes
• Microprojectile bombardment
ER
(A. rhizogenes) • DEAE
(biolistic gene transfer)
 GERMPLASM CONSERVATION
G
 The most successful method to conserve the genetic traits of endangered and
N
commercially valuable species.
FI
 Germplasm is a live information source for all the genes present in the respective
R
plant, which can be conserved for long periods and regenerated whenever it is required
in the future.
U
YO
GERMPLASM CONSERVATION
APPROACHES
AT
EX-SITU (outside site:

conservation away from natural
habitats)
T
PA
Conventional In vitro Field gene banks

G
Orthodox seed Recalcitrant seed, Clones, DNA Plant conservation

F
and Pollen
PD
Slow growth Botanical garden Arboreta

Tissue culture Cryopreservation
E
PL
IN-SITU (inside site:

conservation in their natural
M
habitats)
SA
Natural habit On farm
Wild life sanctuaries Biosphere reserves

Farmer fields/home Tribal areas
/ Genetic reserves
gardens
Natural parks

As the temperature of the mixture is slowly cooled to about 55 ˚c ,

Renaturation the primers base pair with the complementary regions flanking target
DNA strands.
Taq polymerase is commonly used for this purpose. It is done at a
temperature of 75-80 ℃ (72℃). The DNA polymerase adds nucleotides
Synthesis
in the 5’-3’ direction and synthesis the complementary strand of the
S
DNA template.
P
TI
ER
 The father of immunology was Edward jenner (1749 – 1823)
G
 The immune system way of protecting the body against an infectious disease.
N
FI
R
U
YO
AT
T
PA
G
 DIFFERENCE BETWEEN INNATE AND ACQUIRED IMMUNITY

F
INNATE IMMUNITY ACQUIRED / ADAPTIVE IMMUNITY

PD
Resistance to infection that an individual Resistance to infection that an individual

possesses from birth. acquires during his lifetime.
E
Immune response occurs in minutes. Immune response occurs in days.

Prior exposure to the antigen is not Develops following the antigenic
PL
required. exposure.
Diversity is limited, acts through a More varied and specialized responses.
M
restricted set of reactions.

SA
Immunological memory responses are Immunological memory responses are

absent. present.
Components :- Components :-
Skin, Mucosa, Neutrophils, Macrophages, T cells, B cells and Cytokines (IL-2, IL-4, IL-
Monocytes, Natural killer, Mast cells, 5, IFN-𝛾)
Dendritic cells and Cytokines (IL-1, IL-6, IL-
8, IL-12, IL-16, IL-18)

P S
TI
ER
 Microorganisms are living organisms that are usually too small to be seen clearly with
the naked eye.
G
 Microrganisms are used to make different
N
products. (e.g. Penicillin, Streptomycin,
FI
Chloromycetin), vaccines, vitamins, enzymes and
many more important products.
R
 At present there is general agreement to include
five major groups as microorganisms.The U
YO
subdivisions are
 The diameter of microorganisms are 1 mm or less
 Microorganism play an important role in the recycling of organic and inorganic material like
AT
C, N and S cycles, and maintain the stability of the biosphere.

T
PA
G
F
PD
 DISCOVERY OF MICROBES & THE DAWN OF MICROBIOLOGY

 The term microbiology was given by French chemist Louis Pasteur (1822-95).
E
 Antonie van Leeuwenhoek is considered as the “Father of microbiology” & “Father

PL
of bacteriology”.
 Pasteur in 1862 suggested that mild heating at 62.8°C (145°F) for 30 minutes
M
 The process was called Pasteurization.

 Domagk was awarded Nobel prize in 1939 for the discovery of the first sulpha drug.
SA
 Recombinant Hepatitis B vaccine developed in 1982.

 The discovery of microbiology as a discipline could be” traced along the following
historical eras:
Discover y Transition Golden In 20th Century :

PHARMACEUTICS : MICROBIOLOGY
(2) Peplomer
 Peplomer are the glycoprotein and appear as projecting spikes.
 It helps for attachment.
(3) Nucleic acid
 It contains DNA or RNA at a time.
 REPRODUCTION OF VIRUS
SP
TI
ER
G
N
FI
R
U
YO
 VIRAL DISEASES AND THEIR CAUSITIVE MICROORGANISMS

AT
S.NO VIRUS DISEASE

1 Adenovirus Respiratory tract infection and conjunctivitis
T
2 Arbovirus Yellow fever, dengue, Dandly fever

PA
3 Corona virus Lymphocytic Chriomeningitis

4 Herpes Respiratory tract infection & GIT
5 Myxo virus Herpes simplex, (cold sore), chicken pox
G
6 Papova virus Papilloma virus

F
7 Paramyxo virus Mumps, new castle, measles

PD
8 Picrona virus Larger group include

 Poliomyelitis
 Epidemic myalgia
E
 Common cold due to rhinovirus

 Foot & mouth in domestic animal
PL
9 Pox virus Respiratory tract infection and diarrhea

10 Retro virus AIDS
M
11 Rhabdo virus Rabies

SA
12 Hepatitis B & Hepatocellular carcinoma

hepatitis C
virus
13 Papillomavirus Cervical carcinoma, anal carcinoma
14 Epstein-Barr Hodgkins disease, nasopharyngeal carcinoma
virus

819
14 Framycetin Bacillus pumilus A 32-35 C

Bacillus subtilis
15 Neomycin Staphylococcus A 32-35 C
epidermidis
16 Novobiocin Staphylococcus A 32-35 C
epidermidis
17 Oxytetracycline Staphylococcus aureus A/B 32-35 C
S
18 Spiramycin Bacillus pumilus A 32-35 C
P
19 Tetracycline Staphylococcus aureus A/B 32-35 C
TI
20 Tylosin Staphylococcus aureus B 32-35 C
ER
G
N
FI
 DEFINITIONS
R
Vaccine is biological preparation that provide acquired immunity to a
particular disease. It contain agent resembles to disease causing
Vaccines
microorganism. U
YO
Edward Jenner discovered first vaccine (Small Pox)
Toxoids are the inactivated toxin in which toxicity is suppressed by heat or
Toxoids
chemical which promote immune response against bacterial toxins.
AT
VACCINES
T
PA
Killed Live
(inactivated) attenuated
vaccines vaccines
G
F
BACTERIAL VIRAL BACTERIAL VIRAL

Bacillus Calmette
PD
• Typhoid-paratyphoid • Poliomyelitis inactivated • • Poliomyelitis oral

(TAB) (IPV: Salk vaccine) Guerin (BCG) vaccine (OPV, Sabin)
• Vi Typhoid • Rabies ( Chick embryo • Typhoid Ty21a • Mumps
polysaccharide cell : PCEV) (oral) • Measles
• Cholera • Rabies (Human diploid • Rubella
E
• Whooping cough cell : HDCV) • Varicella

TRICK – TB
PL
• Meningococcal • Rabies (Vero cell : PVRV)

• Haemophilus • Influenza TRICK – MMR OPV
influenza type B • Hepatitis B Toxoids
• Plague • Hepatitis A
M
• Tetanus
SA
TRICK – MEN WHO TRICK – HE is IN PvR • Diphtheria

HAte TV, PC, TAB
Antiserum is human or non-human blood serum containing

Antiserum monoclonal or polyclonal antibodies & it acts against many infections
by passive immunity
Antitoxin Antitoxin is antibody with ability to neutralize a specific toxin

PHARMACEUTICS : MICROBIOLOGY
 VACCINE COMPOSITION
1. Antigenic material (Killed or attenuated)

2. Stabilizer monosodium
3. Adjuvant: Increase the immune response
4. Preventative (Antibiotic, Formalin, Thiomersal)
S
 STEPS IN VACCINE PREPARATION
P
TI
Selecting the strains for vaccine production
ER
Up-stream
processing
G
Growing the micro-organism
N
FI
Isolating and purification of micro-organism
R
U
Inactivation of organism
YO
Down-stream
process
Formulation of vaccine
AT
T
Quality control and lot release

PA
 VACCINE PREPARATION FROM EMBRYONATED EGG

G
F
PD
E
PL
M
SA

825
PHARMACEUTICS : PHARMACEUTICAL MANAGEMENT
SP
TI
ER
 Harold Koontz and Heinz Weihrich defined management as, “The process of designing
and maintaining an environment in which individuals working together in groups
G
efficiently accomplish selected aim”.
 When the principles and practices of management are applied to pharmaceutical
N
industry and drug store, it is known as “Pharmaceutical Management”.
FI
 FUNCTION OF MANAGEMENT
R
Primary function of Planning, Organizing, Directing, Coordinating,
management U
Controlling, Staffing, Leading
YO
Secondary function of Decision making, Leadership, Delegation of
management authority/responsibility
Founder of modern Henri Fayol
AT
management methods
Father of management Peter Drucker
T
theory
Inputs of Management Human, Capital, Managerial, Technological, Goals
PA
Outputs of Management Products, Services, Satisfaction, Goal integration,

Profits
G
SWOT analysis Strength, Weakness, Opportunity, Threats

P-D-C-A Cycle Plan, Do, Check, Act
F
PD
 LEVELS OF MANAGEMENT
• Chief Executive Officer, Chief Marketing Officer, Chief Sales Officer,

E
Top Chief Technology Officer, President, Managing Director

PL
• Marketing Manager, Purchase Head, Sales Manager, Operations

Middle Manager, Branch Manager, Finance Manager
M
SA
• Supervisor, Foreman, Clerk, Junior Managers, Inspectors

Low
 Management by objective (MBO) defined as a management system that measures

employees’ performance against a series of set targets or goals to gauge their overall
performance in their role.

829
P S
TI
ER
G
N
Fig :- Process of MBO
FI
 MBO as explained by Peter Drucker.
 MBO is most closely associated with goal setting theory of work motivation.
R
U
YO
AT
 Planning is referred to forecasting future circumstances and requirements, deciding

objectives, making long-term and short-term plans, determining policies and setting
standards.
T
PA
 Planning is classified
Corporate planning, Functional planning, Strategic Planning, Tactical planning
G
 Process of planning
F
PD
E
PL
M
SA
 Forecasting is the process of projecting past sales demand into the future.

 Human Resource Development (HRD) is the framework for helping employees develop
their personal and organizational skills, knowledge, and abilities.
P S
TI
ER
G
N
The General Agreement on Tariffs and Trade (GATT) was signed by 23 countries in October
FI
1947, after World War II, and became law on Jan. 1, 1948.
 The purpose of the GATT was to make international trade easier.
R
 In 1995, the GATT was absorbed into World Trade Organization (WTO), which extended it.
U
YO
AT
T
PA
G
F
PD
E
 Officially commenced on 1st Jan 1995 under the Marrakesh Agreement.

PL
 Signed by 123 nations in 1994.

 WTO had replaced GATT (General agreement on tariffs and trade).
M
 They deal with agriculture, textiles and clothing, banking, telecommunications,

SA
government purchases, industrial standards and product safety, food sanitation

regulations, intellectual property.
 Location :- Geneva, Switzerland
 Established - 1 January 1995
 Created by - Uruguay Round negotiations (1986-94)
 Membership - 162 countries since 30 November 2015
 Head - Roberto Azevedo (Director-General)


85beb4c0-49be-4351-b700-ee2fc36a7ab6

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

85beb4c0-49be-4351-b700-ee2fc36a7ab6

Uploaded by

Copyright:

Available Formats

SA

Solids cannot be Liquids can be Gases can be highly Highly

compressed compressed compressed compressible

 Crystal lattice is constructed from repeating units called unit cells.

 External appearance of a crystal is described by crystal habits, such as needles, prisms,

crystalline species with different internal lattice.

 The crystal form of sulphacetamide is Orthorhombic.

o Rotating cylinder method

1.12 – 1.18 Good 11-15

1.19 – 1.25 Fair 16-20

1.35 – 1.45 Poor 26-31

>1.60 Very- very poor  38

C. Dispersibility :- The ability of a material to flow or pour easily over a plane.

Dispersibility (%) = × 100

equilibrium pressure of gas at constant x

 Equations which defines adsorption isotherms

S. NO. TYPES EQUATION ABBREVIATION

2. Freundlich adsorption Log = Log k + Log p y  Mass of gas

isotherm adsorbed per unit

considered to be originated from

Inscription • It is the main part of the

prescribed) • It contains the names and

Subscription • In this part the prescriber gives

regarding the dosage form to be

Signatura • To be placed on the label.

Patient) • The signatura written in English

and use some Latin abbreviations

3. T.B. Hospital • Civil hospital Community hospital

medicine • AIIMS/PGI Charitable hospital

Large Hospitals Beds 1000 and above

Medium Hospitals Beds between 500 – 1000

Small Hospitals Beds between 100 – 500

 FLOOR SPACE REQUIREMENT

2. Parenteral solutions laboratory 185 200

measures pressure at a measure the difference measures the minute

 U tube fluid manometer or vessel containing in a fluid contained in a

USES USES USES

consumption of gases in even small gas pressures increases the accuracy of

chemical reactions.  Used in measurement of the pressure determination

 Jabir ibn Hayyan is discovered distillation.

Thermometer Cold water in

Vapor Receiving flask

PHYSICAL CHEMICAL ORGANOLEPTIC

CHARACTERISTICS CHARACTERISTICS CHARACTERISTICS

Bulk characteristics Oxidation & Reduction Colour

Solubility analysis Photolysis Odour

Stability analysis Polymerization Taste

FACTORS AFFECTING STABILITY OF DRUG

INTERNAL FACTORS FORMULATION ENVIRONMENTAL

IV Low Low Poorly Taxol, Chlorothiazide,

 SOLID DOSAGE FORM

SOLID DOSAGE FORM

 Soluble Tablets  Hard gelatin  Dry seal Fine powders Granules

Dusting powder Insufflation Dental powder

 Dispersions where Active Pharmaceutical Ingredient of low solubility is dispersed in

• Topical suspension (Calamine Lotion)

 TERMINOLOGY RELATED WITH SUSPENSION

Swamping Increase in concentration of ions in the solution decrease the

Subsidence Describe the settling of an aggregated system (flocculated system)

Ostwald Cyclization changes in temperature in suspension to form crystal

cycling stability testing purpose

Levigation Particle size reduction by grinding

 DIFFERENT BETWEEN FLOCCULATED & DEFLOCCULATED SUSPENSION

FLOCCULATED SUSPENSION DEFLOCCULATED SUSPENSION